Pages: 1 [2] 3 4 ... 8   Go Down
Print
Author Topic: Dehiscence  (Read 22789 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #30 on: December 13, 2017, 02:31:27 AM »

Model Number 106
Event Date 02/23/2016
Event Type Death
Event Description
It was reported that a vns patient who recently had a generator replacement was scheduled to have their generator programmed on, but had a slight gap in the incision site. Tape was placed over the site and the patient was rescheduled to have it turned on at a later date. On the day that the patient was scheduled to visit the physician to have the device turned on, he was found dead in his bed. Follow-up by the company representative revealed that it was the neck incision that had opened and there was no presence of infection. The cause of death is unknown to-date. Additional relevant information has not been received to-date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5522718
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #31 on: December 15, 2017, 01:56:36 AM »

Model Number 106
Event Date 03/18/2016
Event Type Injury
Event Description
Per clinic notes received, both neck and chest incision nicely healed with no sign of infection.

Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient's generator incision site had opened postoperatively and that the generator was visible. Patient went to ed and the physician closed the wound under sterile conditions with derma bond. Patient was discharged from the ed with 2 weeks worth of antibiotics. Patient did not report any discomfort but was able to see the generator. Patient was occasionally able to see yellow discharge from the wound. Patient is overall tolerating the stimulation well. No fevers or other signs of infection were present. The chest would was 90% healed with small dehiscence in the center of the wound, exposing the generator. Mild erythema to the wound edge was also present. Vns was interrogated and programmed to 2. 0mamp with no lead impedance noted. Due to infection, the patient later underwent generator was explanted on (b)(6) 2016. The explanted generator has not been received to date. A review of device history records showed that both the lead and generator were sterilized prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5621104
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #32 on: December 16, 2017, 01:41:43 AM »

Model Number 106
Event Date 03/15/2016
Event Type Injury
Event Description
It was reported on (b)(6) 2016 that the patient's wound has opened up. The vns was recently implanted on (b)(6) 2016. The wound opening was first noticed on (b)(6) 2016. It is believed that the child did a bear crawl when he was playing which may have caused the wound to open. The patient went to the er on (b)(6) 2016 because the site would not close. The physician closed up the site and it was stated that the site was infected and the patient was provided with some medication to remove the infection. The device was not explanted. The physician does not think that the device has the infection on it so he chose not to explant. They plan to monitor the patient.

Event Description
The design history record for the lead was reviewed and the device was hp sterilized prior to distribution into the field.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5563449
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #33 on: December 16, 2017, 01:42:32 AM »

Model Number 106
Event Date 03/04/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient had been picking at her incisions from her vns implant surgery. The incisions were slightly gaping as dehiscence wounds, and dermabond was applied to close the chest and neck incision sites. At the time of the initial report, the patient said that the incisions were healing and closed. There was no redness, oozing, or signs of infection at that time. Further information was received that the patient's neck incision was subsequently oozing pus, and the site was swollen red and painful. The symptoms began on (b)(6) 2016. The patient subsequently followed up with the surgeon's office for an appointment. She was treated with antibiotics to address a superficial infection. It was believed that the infection was also likely caused by patient influence at the surgical site. A review of device history records showed that both the lead and generator were sterilized prior to distribution. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5574698
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #34 on: December 17, 2017, 02:09:04 AM »

Model Number 105
Event Date 05/02/2016
Event Type Injury
Event Description
It was reported that the patient has drainage at the vns site. The patient was referred to the surgeon for evaluation. Review of device manufacturing records for the generator confirmed sterilization prior to distribution. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date. The patient had undergone generator replacement in (b)(6) 2015 due to wound dehiscence (mfr. Report # 1644487-2015-03969).

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5682344
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #35 on: December 17, 2017, 02:09:43 AM »

Model Number 106
Event Date 05/05/2016
Event Type Injury
Event Description
It was reported that the patient's generator incision was not healing well following replacement surgery and that the incision was open. The patient underwent an outpatient procedure where the incision was found to be small and superficial. No vns product was exposed. The incision was cleaned and sutured closed. Since the outpatient procedure the surgeon reports that the incision is healing well. Review of device manufacturing records for generator confirmed sterilization prior to distribution.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5682673
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #36 on: December 17, 2017, 02:10:32 AM »

Model Number 105
Event Date 04/12/2016
Event Type Injury
Event Description
It was initially reported that the patient's generator could be easily moved. At the time of the initial evaluation, the surgeon decided it was not medically necessary to proceed with surgery to address issues with the device migration. A non-absorbable suture was used to secure the generator at the time of the last generator replacement surgery. A subsequent report from the patient on (b)(6) 2016 indicated that she was actually proceeding with surgery. Further information indicated that there issues with seepage from the chest wound and device migration and protrusion. Follow up after her report indicated that her vns system was fully removed on suspicion of infection following a visit to the er and hospital admittance, and she was subsequently released from the hospital. Information received from the explanting surgeon's office confirmed that the patient's system was fully removed. The patient was admitted in-patient on (b)(6) 2016. The generator was reportedly extruding through a dehiscence wound. The generator was removed on a suspected infection in the chest. The lead was also removed to allow for full recovery, although there was no suspicion of infection in the neck. An antibiotic was prescribed. The pathology report for cultures showed negative or negligible for all tests, and showed no growth in culture media. The suture had to be cut for generator removal, indicating it was still intact before explant. No further information was given on potential causes or contributing factors to the device migration, protrusion, or extrusion. The explanting facility does not return explanted products per their internal policy, so return of the removed devices is not expected. The generator device history record was reviewed and found all specifications were met prior to distribution, and the generator was sterilized prior to distribution.

Manufacturer Narrative
(b)(4).

Event Description
Clinic notes were received with information on the patient's medical history. Some conditions were identified that may limit blood supply to certain regions of the body and contribute to wound healing difficulties. The surgeon did assess that he patient did not have risk factors for skin deterioration. However, his awareness of the patient's past medical history was uncertain. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5688800
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #37 on: December 20, 2017, 08:26:11 AM »

Model Number 105
Event Date 05/23/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that a patient's incision site had opened up to where the generator was visible. The patient got into a fight and the stitches in the chest had come undone. The patient had generator replacement surgery on (b)(6) 2016. The physician elected to redo the patient's stitch. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5725773
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #38 on: December 21, 2017, 02:38:12 AM »

Model Number 106
Event Date 05/04/2016
Event Type Injury
Manufacturer Narrative
Suspect medical device udi: (b)(4).

Event Description
It was reported that the generator site was open and the generator was exposed. The patient was recently implanted on (b)(6) 2016. The patient was then referred for surgery to irrigate the site and close the incision. Further follow-up found that the patient has a history of picking at his skin during a seizure. The patient reported to the neurologist that he had a seizure and afterwards the generator incision was found to be open. The patient underwent surgery where the incision site was irrigated with antibiotic solution and the incision was closed. The generator was not replaced during this surgery. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5718792
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #39 on: December 22, 2017, 03:24:55 AM »

Event Date 12/01/2010
Event Type Injury
Event Description
It was initially reported by the physician that the pt had an infection and was going to undergo surgery to have her vns generator replaced. Pt was hospitalized due to infection and it was informed that her incision site was opening up and they could see the generator. The surgeon plans to replace the generator and put the new generator in a new pocket. Good faith attempts to obtain additional info has been unsuccessful till date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1943813
« Last Edit: January 31, 2018, 01:43:04 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #40 on: December 23, 2017, 01:58:40 AM »

Model Number 103
Event Date 11/30/2011
Event Type Injury
Manufacturer Narrative

Event Description
A pediatric epilepsy nurse specialist in the united kingdom reported that they had a vns patient who has had ongoing problems with wound breakdown following vns surgery last (b)(6) (2011). A decision was made to explant the device. The patient has an extensive history of interventions taken to try to prevent the device being explanted and resolve their infection. Date the event 1st observed - was (b)(6) 2011. The patient was admitted to a children's ward with a chest infection. Discharged on (b)(6) 2011 with 1 week oral antibiotics. (b)(6) 2011 - neck wound inflamed (wound swab - scanty growth (b)(6)) treated with 7 days oral flucloxacillin. (b)(6) 2011- wound improving. (b)(6) 2011 - wound improving but not completely healed so continued on oral flucloxacillin. (b)(6) 2012 - wound not completely healed but no sign of infection. (b)(6) 2012 - debridement of neck wound - discharged on oral flucloxacillin. (b)(6) 2012 - neck wound clean; dry. (b)(6) 2012 - admitted to ward with infection in chest and neck wound - 3 weeks if iv antibiotics as an inpatient followed by 3 months oral antibiotics. (b)(6) 2012 - scab remained over neck wound - wire near surface. (b)(6) 2012 - neck wound explored and wire re-positioned. No evidence of infection. (b)(6) 2012 - wounds clean and dry - 3 months of oral antibiotics finished (b)(6) 2012 - area around chest wound appeared swollen but do evidence of infection or wound breakdown. (b)(6) 2012 - chest wound breakdown - no growth on wound swab. (b)(6) 2012 - wounds debrided and re-sutured. (b)(6) growth from tissue sent. Commenced iv antibiotics. (b)(6) 2012 - discharged home on once a day iv antibiotics by community nurses. (b)(6) 2012 - re-admitted with discomfort around chest wound, increased seizures and fluid collection under chest wound. (b)(6) 2012 - device and leads removed. Leads and tissue sent for flu culture - no growth after 48hrs. Continues in iv antibiotics. It was reported that the wound dehiscence and the infection were not related to the vns or the implant procedure although the patient's device was explanted related to the event. Patient manipulation or trauma did not occur that is believed to have caused/contributed to the wound dehiscence or the infection. No causal or contributory medication changes preceded the onset of the dehiscence or the infection. The infection was located at the neck wound. The neck location was re-explored in (b)(6) 2012 as electrodes were near the surface. The lead was re-positioned at this time.

Event Description
The explanted generator was returned for analysis. The lead was discarded. Completion of the generator analysis is pending.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the lead and generator prior to distribution.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the lead and generator prior to distribution.

Event Description
The patient's explanted generator was returned for analysis. Results of diagnostic testing indicated the device was operating properly and communicated properly. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

Event Description
Additional information was received. That the patient's increase in seizures were above their pre-vns ratethe patient was given more anticonvulsant medication for the increased seizures. They were possibly due to the ongoing infection.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2777435
« Last Edit: March 20, 2018, 01:28:43 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #41 on: December 26, 2017, 02:31:27 AM »

Model Number 106
Event Date 07/15/2016
Event Type Injury
Event Description
Follow-up from the surgeon 10/14/2016 provided that the patient's incision opened right after the surgery due to the patient picking at it. The wound opening was superficial only and healed up after local care.

Event Description
It was reported by a vns patient's implanting physician that the patient's incision on his back had opened. It was noted that only the skin had opened and the generator looked covered. The physician said the intact skin was reinforced with steristrips. The local care for the wound would be provided by patient's parents. Additional relevant information has not been received to-date.

Manufacturer Narrative
Suspect device udi: (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5870030
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #42 on: December 29, 2017, 01:47:57 AM »

Model Number 106
Event Date 06/26/2016
Event Type Injury
Event Description
The review of the manufacturing records confirmed the sterilization with (hp method) for the lead prior to the distribution. Further follow up indicated that the lead was not replaced.

Manufacturer Narrative

Event Description
It was reported that vns patient underwent a generator replacement. The reason mentioned on the implant card was "patient cut the incision". The lead impedance was ok after the replacement. The explanted generator was implanted on (b)(6) 2016. Further follow up indicated that the patient (mentally delayed) was implanted with the vns therapy since 2010 with positive outcome. He was admitted to the general hospital in the remote region on (b)(6) 2016, where they looked over the incision, they cleaned the wound, and stick dressing on the wound. While visiting the vns clinic as regular procedure to ramp up the device on (b)(6) 2016, they looked over the incision and found out the wound was open (patient was trying to remove out the device). The patient was admitted directly to the or for the next day on (b)(6) 2016 to clean and seal the wound. The neurosurgeon decided to replace the generator prophylactically; he cleaned the wound and changed the position of the generator in order not to have any infection. No explanted device is available to be returned to the manufacturer for analysis. The review of the manufacturing records confirmed the sterilization with (hp method) for the generator prior to the distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5942292
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #43 on: December 30, 2017, 01:50:05 AM »

Model Number 105
Event Date 07/01/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
Product analysis was completed on the returned lead portion on (b)(6) 2016. Note that a portion of the lead body including the electrodes was not returned for analysis. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity checks of the returned lead portion were performed with no discontinuities identified. There is no evidence to suggest an anomaly with the returned portion of the device. Product analysis was completed on the returned generator on (b)(6) 2016. Visual examination showed only explant-related observations; no surface abnormalities were noted on this device. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 3. 074 volts and showed an ifi=no condition. Review of the internal device data showed no anomalies, with any noteworthy impedance changes occurring after the device explant. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
It was reported that the patient's generator site incision opened up. A revision surgery was planned, but the surgeon had assessed that the full vns system required removal. An infection was reportedly confirmed at that time, and the lead was extruding and in the infected area prior to removal. The explant procedure occurred on (b)(6) 2016. The explanted generator and lead were received for product analysis on 08/23/2016. Follow up with the surgeon's office showed that the patient's generator site opened in approximately (b)(6) 2016. Prior to the incident, the patient had developed a white bump over his generator site. His caregiver had scratched it off and caused bleeding, and the patient went to the er. Cellulitis and infection was suspected prior to the explant surgery. A review of device history records showed that both the lead and generator were sterilized prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5925113
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #44 on: December 31, 2017, 02:18:37 AM »

Model Number 103
Event Date 01/01/2014
Event Type Injury
Event Description
It was reported that the patient would not leave the site alone, so the wound would not heal properly. The physician stated that there was no relationship to the wound dehiscence and vns.

Event Description
It was reported that the patient¿s generator was explanted on (b)(6) 2014. The explanted generator was received for analysis. Analysis of the generator was completed on (b)(6) 2014. Analysis showed that the pulse generator performed as expected and no adverse conditions were found with the device. Further follow-up revealed that the device was explanted due to multiple episodes of wound dehiscence. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4440927
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #45 on: December 31, 2017, 02:19:34 AM »

Model Number 106
Event Date 09/27/2016
Event Type Injury
Event Description
It was reported that the patient had presented with a dehiscence wound several months after the device had been explanted due to infection. The wound had not completely healed and he was placing vaseline on the wound. No additional relevant information has been received to date.

Event Description
It was reported that the patient was having his vns generator explanted due to infection. Further follow-up found that the patient presented with purulent drainage at the generator site. The patient underwent a wound cleaning procedure for the infection however the surgeon then elected to remove the generator. The lead was cut and the portion of the lead with the electrodes was left implanted. Samples from the infection were sent to the microbiology lab however the results from the microbiology testing have not been received to date. Manufacturing records for the generator were reviewed and it was noted that it was sterilized prior to distribution. No additional relevant information has been received to date.

Manufacturer Narrative
Corrected data: evaluation codes: this information was inadvertently reported incorrectly on mfg. Report 0.

Manufacturer Narrative
Suspect medical device udi: (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6053715
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #46 on: December 31, 2017, 02:20:47 AM »

Model Number 106
Event Date 09/17/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient picked at his previous generator site and caused the surgical scar to experience dehiscence and minor bleeding. The patient visited the emergency room, and the wound was addressed by being re-sutured. The patient's treating physician believes that the patient's manipulation of the would caused the dehiscence and bleeding. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6028328
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #47 on: January 01, 2018, 02:23:46 AM »

Model Number 105
Event Date 10/13/2016
Event Type Injury
Event Description
The explanted generator and lead were received by the manufacturer for analysis. Product analysis is expected; however, it has not been completed to date.

Event Description
Product analysis (pa) for the returned generator and lead was completed. The allegation of infection was noted to be beyond the scope of the activities performed within the pa laboratory environment. However, potential contributing factors to this condition were considered/evaluated and none were found to exist. The generator diagnostics were as expected for the programmed parameters. The electrical test showed the generator performed according to functional specifications. There were no performance or any other types of adverse conditions found with the generator. Other than typical wear and explant related observations, no other anomalies were identified with the returned portion of the lead. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary could not be made on that portion.

Manufacturer Narrative
(b)(4).

Event Description
It was reported the patient had an infection, which was first observed, on (b)(6) 2016. The patient's family had noted on (b)(6) 2016, prior to a normal scheduled follow-up visit on (b)(6) 2016, that they had observed some swelling and the generator implant location. The infection was confirmed on (b)(6) 2016 at the follow-up appointment and the patient had a chest ultrasound due to the infection on (b)(6) 2016. The patient underwent a full explant surgery on (b)(6) 2016. It was noted prior to surgery on (b)(6) 2016 that there was actually wound dehiscence which had occurred between (b)(6) 2016 and the surgery date. It was noted the reason for the infection is believed to be the fact that the generator was implanted in the axillary region and the patient is in a wheelchair and the sweat may be a contributing factor to the cause of the infection. Review of the dhrs for both the lead and the generator confirmed sterilization prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6055616
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #48 on: January 01, 2018, 02:24:43 AM »

Model Number 103
Event Date 12/12/2011
Event Type Injury
Event Description
Additional information was received that the patient may have their vns device reimplanted in the future. No surgery date is set at this time.

Event Description
Additional information was received that the patient would go to surgery (b)(6) to have their generator reimplanted. Since their explant the patient has been having multiple daily seizures, she is very difficult to take care of and can be very aggressive. The infection was a (b)(6) and they were treated with antibiotics for approximately 2 weeks.

Manufacturer Narrative

Event Description
Additional information was received about the patient's vns explant surgery. It was reported that the patient had recently had a vns instillation that went very well, she actually had fewer seizures. Her seizures changed in character. With vns they were shorter and less severe and also the power of having the magnet to swipe and stop a seizure. Unfortunately, there was a (b)(6) infection and vns had to be removed. Three days prior to their removal of their vns generator and wound washout their mother noticed that her daughter was having trouble swallowing, and then during a coughing fit, broke open her neck incision and purulent discharge poured forth in a large volume. The patient was brought to clinic and was admitted to the hospital and scheduled for operative removal and washout of her wounds. Since explant the patient continues to have seizures the same as she had previously and her review is again consistent with extremely low functioning. The patient's mother is going to have a consult planned in the future for reimplant of their device.

Manufacturer Narrative
Suspected medical device operator of device corrected data; updated to patient. Corrected data: surgery was (b)(6) 2012. A 30 day report omitted of initial report.

Event Description
It was reported that the patient's incision site looked raised, but was not red per physician. The patient had the vns device removed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2414468
« Last Edit: February 21, 2018, 02:02:33 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #49 on: January 02, 2018, 02:20:54 AM »

Model Number 106
Event Date 08/10/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient was scheduled for surgery to reposition, the vns generator in a different location. The reason for the repositioning surgery was not immediately known. Further follow-up found that the patient presented with an infection after a recent generator replacement surgery. Review of the manufacturing records confirmed that the generator was sterilized and passed quality control inspection prior to distribution. The generator was repositioned during a surgery on (b)(6) 2016 where it was kept in the left chest however it was moved to a new location. After being repositioned, a diagnostic test found an impedance value the within acceptable range. No additional relevant information has been received to date.

Event Description
It was reported that following the repositioning surgery the patient developed a dehiscence wound which required additionally surgery to close the wound. At the time of the report the dehiscence wound did not appear to be related to the original infection therefore the dehiscence wound event was reported in mfg report #1644487-2017-03189. It was later reported that fluid then began to build in the pocket and the patient was again referred to surgery to drain the pocket and explant the generator. During the surgery fluid was observed inside the lead. The surgeon was concerned that the fluid leaks in the lead could have been a contributing factor for the infection issues that were previously reported in this report and in mfg report #1644487-2017-03189. The fluid leaks in the lead and dehiscence wound events are being reported in mfg report #1644487-2017-03189. While this report will only capture the initial infection that occurred after the generator replacement surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6113549
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #50 on: January 02, 2018, 02:21:45 AM »

Model Number 106
Event Date 07/26/2016
Event Type Injury
Event Description
It was reported that the patient underwent generator explant surgery. No additional relevant information has been received to date.

Manufacturer Narrative
Suspect medical device udi: (b)(4).

Event Description
It was reported that the following generator replacement surgery the patient presented with a dehiscence wound at the generator incision site. The surgeon denied the presence of an infection. The surgeon believed the dehiscent wound was related to the generator replacement surgery. The manufacturing records of the generator were reviewed and it was observed that the generator was sterilized and passed qc inspection prior to distribution. The generator was turned off and the patient was later referred for generator explant surgery. However no surgical interventions are known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6100938
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #51 on: January 03, 2018, 02:09:50 AM »

Model Number 102R
Event Date 11/01/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient's generator wound incision had opened was found to be approximately 0. 5 cm and after a week it continued getting larger with clean edges. There is no sign of infection but the patient was placed on a prophylactic antibiotics. The open wound was covered with a sterile dressing. The patient was evaluated by the surgeon who decided to refer the patient for surgery to replace the generator and close the open wound. The surgeon noted that there was erosion over the area of the generator and the generator was exposed. Neither the neurologist or surgeon could determine why the incision opened. Manufacturing records of the generator showed that the generator was sterilized prior to distribution. The patient underwent generator replacement surgery. Diagnostic testing was reportedly performed a week prior to the surgery and the results were within the acceptable range. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6158915
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #52 on: January 03, 2018, 02:10:52 AM »

Model Number 106
Event Date 09/19/2016
Event Type Injury
Manufacturer Narrative
Date of event, corrected data: supplemental mdr #1 inadvertently reported an inaccurate event date. The infection likely began prior to when the physician first noticed it in clinic. Therefore the date of implant is a more appropriate event date. Describe event or problem, corrected data: initial and supplemental #1 mdr inadvertently left off the increase in seizures the patient experienced following a settings change. Relevant tests/laboratory data, including dates, corrected data: initial and supplemental #1 mdr inadvertently left off the settings from (b)(6) 2016.

Event Description
Information was received which indicates that the patient had their generator explanted due to an infection that was believed to have been caused by either the patient picking at the incision site or drooling on the incision site. The patient was then explanted and the leads were cut. The device history record was reviewed for both the patient's lead and generator. The generator was sterilized prior to leaving the facility and had a sterilization expiration date of 03/22/2018. The lead was sterilized prior to leaving the facility and had a sterilization expiration date of 10/01/2004. The explanted devices were disposed of by the explanting facility. No return is expected. No other relevant information has been received to date.

Manufacturer Narrative
(b)(4).

Event Description
The patient's caretaker reported that the patient experienced an increase in seizures following a settings change on (b)(6) 2016. The seizure log with the neurologist indicated that the patient had one 2 minute seizure on (b)(6) 2016. The patient's settings were then adjusted on (b)(6) 2016. Shortly after the patient became ill which may have contributed to the increase in seizures.

Event Description
Information was received from the physician indicating that the patient presented on (b)(6) 2016 with infection and dehiscence wound. The patient's generator was subsequently removed on the same day. No other relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6175461
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #53 on: January 03, 2018, 02:11:41 AM »

Model Number 106
Event Date 09/24/2016
Event Type Injury
Event Description
It was reported that the patient presented to the er with wound healing issues following recent generator replacement surgery. The patient was evaluated by the surgeon and it was noted that the corner of the generator was exposed. The wound dressings were changed and the patient was prophylactically prescribed antibiotics. The patient was referred for would flap surgery. At a follow-up appointment on (b)(6) 2016, it was noted that the would was healing and was about the size of a dime. Additionally, the generator was no longer exposed. The patient was once gain prophylactically prescribed antibiotics and given additional wound supplies to continue dressing the wound. A few weeks later, the patient's care home reported that the patient had been "horsing around with a friend" which caused the wound to open again and the generator was exposed. When the patient was evaluated by the surgeon on (b)(6) 2016, the generator and lead were out of the pocket. It was noted that the lead was broken. The surgeon then explanted the lead and generator in the office and the explanted products were given to the patient's caregivers. The wound flap surgery was then canceled. A review of manufacturing records showed that the generator was sterilized prior to distribution.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6117942
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #54 on: January 05, 2018, 03:36:51 AM »

Model Number 102R
Device Problem No Known Device Problem
Event Date 01/24/2017
Event Type Injury
Event Description
A call was received from the hospital requesting a product return number as the patient had undergone vns generator and lead explant due to wound dehiscence. The patient had been admitted to the er a few days prior to the explant surgery due to an unrelated issue, and the physician reported to the surgeon that he was able to see the generator through the patient's incision. It was confirmed there was no sign or suspicion of infection. Review of the dhr for the generator confirmed sterilization prior to distribution.

Manufacturer Narrative

Event Description
Product analysis (pa) for the returned generator was completed. The reported ¿extrusion/generator¿ allegation is beyond the scope of the activities performed in the pa laboratory. During analysis, it was found that the device performed according to functional specifications and concluded that no abnormal performance, or any other types of adverse conditions, was found. It was later reported by the physician's office that they believe the patient had picked at the incision, which caused the extrusion. Pa for the returned lead was completed. The allegation of extrusion is not an actionable issue which will result in confirmation of an event and identification of a casual factor in the pa laboratory environment. Note that the lead assembly, including the electrode section, was not returned for analysis and thus a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6341897
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #55 on: January 06, 2018, 03:38:02 AM »

Model Number 104
Device Problem No Known Device Problem
Event Date 01/31/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that a vns patient needs to have her vns replaced because her pocket incision had opened and the site was infected. Follow-up to the physician provided that the wound had healed fully post-surgery. He thought the wound opened because the carehome physically lifts the patient on a regular basis. He believed the way they were lifting her caused the device to wear away the skin at the incision site, causing it to open and become infected. Review of manufacturing records provided the devices were sterilized prior to distribution. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6356632
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #56 on: January 07, 2018, 03:23:19 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 09/02/2016
Event Type Injury
Manufacturer Narrative

Event Description
A report was received indicating that an abscess or blister had developed on the patient's chest incision. The reported indicated that the abscess was not leaking but appeared filled with pus and indicated that the wound appeared dehisced. It was unclear what caused the abscess/blister to form. The patient then sought treatment at an er when the abscess/ blister ruptured. The patient was prescribed antibiotics to treat the infection that was found when the abscess/ blister ruptured. The antibiotics reportedly cleared the infection. The device history record for both the generator and lead were reviewed. It was found that both devices had been sterilized prior to leaving the manufacturing facility. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6232562
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #57 on: January 08, 2018, 02:23:18 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 04/01/2006
Event Type Injury
Event Description
It was reported that the patient's vns was explanted two weeks after implant surgery due to infection. It is unclear if the lead and/or the generator was explanted. The manufacturer's device history records of the generator and lead were reviewed and sterilization was confirmed. No further relevant information has been received to date.

Event Description
Operative notes were received that described the patient's explant and wound debridement due to infection. The operating notes indicated that the patient had an eschar over the generator site that opened, revealing the generator itself. For this reason, the site was believed to be infected. The patient was not considered to be septic, toxic, or febrile on exam. It was indicated that the infection was localized to the subcutaneous tissue. The patient's full lead (including electrodes) and generator were explanted. The patient's eschar was removed. No further relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6350406
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #58 on: January 10, 2018, 01:39:18 AM »

Model Number 102
Event Date 12/02/2008
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
Reporter indicated a vns patient had poor wound healing and developed an infection and wound dehiscence at the vns generator and electrode incision sites. The patient's poor wound healing and wound dehiscence are attributed to patient trauma of picking at the incisions, poor hygiene, and possibly coumadin medication. The patient later underwent explant of the vns generator only. The explanted generator has been returned and is currently in product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1381549
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62999


« Reply #59 on: January 10, 2018, 01:40:04 AM »

Model Number 103
Event Date 04/23/2009
Event Type Injury
Manufacturer Narrative
See scanned page.

Event Description
It was reported that a vns pt reopened his chest incision site during a seizure and that the device became visible through the open wound. The pt's implanting surgeon indicated that several medications were administered to the pt to address the wound dehiscence, and that the event eventually led to device explantation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1380341
Logged
Pages: 1 [2] 3 4 ... 8   Go Up
Print
Jump to: