Pages: 1 2 [3]  All   Go Down
Print
Author Topic: Fever  (Read 3079 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #60 on: April 03, 2019, 01:21:04 AM »

Model Number 103
Event Date 04/07/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was admitted to the hospital due to sepsis. The patient was implanted with vns the day prior. The patient developed a fever the night of the implant and was taken to the emergency room the following morning and diagnosed with sepsis. The patient's father reported that the implant procedure took approximately two and a half to three hours and was performed by residents. It was later reported that the patient was doing better and was discharged on antibiotics. Attempts to obtain additional relevant information have been unsuccessful to date. Review of device manufacturing records for both the generator and lead confirmed sterilization prior to distribution.
 
Event Description
The physician's office reported that the sepsis was not related to the vns replacement surgery. The patient reportedly had no history of infections and had the following comorbidities: severe mental retardation and immobility. The patient had also been living in a long-term care facility.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5630893
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #61 on: April 06, 2019, 02:12:11 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/05/2019
Event Type  Injury   
Event Description
The patient¿s mother initially reported that the patient¿s oxygen saturation level was 83 (percent) and the patient¿s heart rate was elevated to 130bpm. The patient¿s breathing was a little rapid and her fingers were semi-purple. Additionally, the patient¿s body temperature was 100. 8 f. Information was later received that the patient was treated for these symptoms at the er and these events were referred to as ¿respiratory infection¿ symptoms. The patient was reportedly feeling better after treatment but it was unknown if the patient was discharged. The patient¿s device was left off per the neurologist¿s request. After the implant surgery and lead impedance was normal at 1955 ohms. A review of device history records for the generator and lead shows that no unresolved non-conformances were found. The device met all specifications for release and were verified to have been sterilized prior to distribution. Follow up with the patient's neurologist determined that the er physician and neurologist assessed that the patient had pneumonia which was not believed to be related to vns therapy or surgery. Additionally, the increased heart rate, fever, and discoloration of skin were assessed to be symptoms of the pneumonia and were unrelated to vns as well. There was no mention of the rapid breathing or hypoxia. The neurologist reported that the most recent update regarding the patient was that she was doing much better. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8465064
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #62 on: April 14, 2019, 01:43:42 AM »

Model Number 105
Event Date 11/15/2016
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported by the patient that she had a generator pocket revision on (b)(6) 2014 for the sake of comfort. It was later explained by the physician's office that the patient initially thought she had an infection as she had a fever and the generator site was red; however, the physician ruled out infection. The patient noted she had a stinging pain which was worse with movement. It was confirmed the surgery was performed due to pain, and not to preclude a serious injury.
 
Manufacturer Narrative
This information was inadvertently incorrectly reported on the initial mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5876872
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #63 on: April 29, 2019, 05:55:06 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/19/2017
Event Type  Injury   
Event Description
It was reported by the patient that he recently had a staph infection around his generator. The patient had gone to the er and was given antibiotics. A day later, he had a fever of 103 degrees f. The patient was later transported and hospitalized and was treated by an infectious control physician. Attempts for additional information have been unsuccessful to date.
 
Event Description
Review of the device history records for both the lead and the generator confirmed sterilization prior to distribution.
 
Event Description
It was reported that the infection began after the patient noticed what appeared to be a pimple and the picked at the incision site. The infection has since resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6359883
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #64 on: May 07, 2019, 07:33:02 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2016
Event Type  Injury   
Event Description
It was reported that a patient had been experiencing fevers and saw an infectious disease physician to determine the cause of the fevers. Numerous tests were performed, but the physician could not identify the cause of the fevers. The patient was referred to have her vns generator explanted to see if that would remedy the fevers. No further relevant information has been received to date.
 
Event Description
The patient had been having fevers since around (b)(6) 2016, and the patient had multiple biopsies and a bone marrow test to try to find the cause of the fevers. The physician referred the patient for explant just to make sure that the vns was not the cause of the fevers and to remove any foreign objects from the patient¿s body. The patient had explant surgery. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6386474
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #65 on: May 30, 2019, 06:25:20 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/21/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.
 
Event Description
A report was received that a patient was hospitalized for an infection. The patient had a high white blood cell count, fever and tenderness at the generator site. A review of the device history record showed both the lead and generator were sterilized per specification prior to release for distribution. Further information was received from the patient's nurse reporting the hospital staff determined the patient had an infection of unknown origin and recovered shortly after being admitted. He was released without any surgical intervention.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6636931
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #66 on: June 01, 2019, 03:38:10 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/14/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported low grade fever and swelling have been determined to not be related to vns therapy. Should surgery occur for the device, evaluation will not be relevant to the report.
 
Event Description
It was reported by the patient that they had been experiencing a low grade fever a neck swelling after the vns implant surgery. Due to the fever and swelling the patient was put on antibiotics by the physician. A review of the manufacturing records was performed and both the lead and generator were shown to have been sterilized prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6724142
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #67 on: June 02, 2019, 07:05:58 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/17/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that a patient developed an infection after a recent generator replacement surgery. The location of the infection was unknown. The patient was hospitalized in the er due to the infection. The patient then experienced status epilepticus due to the infection, so the physician programmed the patient's vns on in response. The nurse did not provide further information about the patient's infection. She reported that the patient had been admitted to the er twice after experiencing status epilepticus, according to her notes. The patient's vns was turned on during the first hospital admission. The patient notably had a fever during the second admission, indicating a possible infection. The patient's status epilepticus resolved after the vns was programmed on in the hospital. Device history records for the generator revealed that the device met all specifications for sterility prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6695427
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #68 on: June 04, 2019, 07:57:04 AM »

Model Number 102
Event Date 08/12/2010
Event Type  Injury   
Event Description
It was initially reported by the (b)(6), that a call was rec'd from the vns pt's mother that her son was having fluid buildup around the vns device. Later, information from the pt's mother indicated that a pocket of fluid was right over top and around the generator. If they touch it, they can definitely feel the fluid, but do not know whether it is blood or fluid. She stated that it covers the whole generator. Her son is implanted with one of the bigger generators and normally they can see the outline of the device under the skin, however now they can't see it at all. The pt was not known to have had any trauma since the pt's sitter/sister are very watchful over the pt. There wasn't any bruising or redness in the area to suggest infection. The pt also had a low-grade temperature over the weekend prior and he was given otc motrin. There was no recurrence of the temperature. There did not appear to be any pain or any discomfort. The pt was also said to have been sleeping longer than before, which started before the site swelling. The surgeon opted to initially monitor the issue. Later it was indicated that the pt was referred for generator explant due to the swelling at the site and to rule out infection as a precaution. Additional information was rec'd from the surgeon's office. It was indicated in the clinic and op notes that the pt's cultures were negative and the wound was benign. The pt was said to be explanted due to the swelling at the site. It was not clear as to what caused the issues reported, but due to the possibility of infection, the pt's device was removed as safety precaution. The physician did not believe the device caused the infection. There was no pus or signs of infection. When asked about the reported fatigue and fever, the notes did not provide any indication of the issue, but was part of the reason he was referred for explant. It was said to have cleared up after explant, but there is no way to determine if it was related to the swelling. The pt was said to have been seen at the emergency room for the low-grade fever and lethargy. The pt was seen on 09/23 for f/u on the recently implanted generator and there was no observable infection. All appeared to be acceptable for the pt. The explanted pulse generator was returned to the manufacturer for analysis, which confirmed there was no device malfunction. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional. There were no performance or any other type of adverse conditions found with the pulse generator. The manufacturer dhrs were searched confirming lead and pulse generator sterilization prior to distribution.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Results: review of manufacturing records confirmed sterilization for both the generator and lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1846171
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #69 on: June 08, 2019, 05:34:53 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/27/2019
Event Type  Injury   
Event Description
It was reported that the patient has had a fever, severe vomiting, and weight loss following vns replacement surgery. The patient was hospitalized, and the patient reported that the physicians believe that the patient has acute gastritis caused by damage to the vagus nerve. The device was not turned on following replacement. The patient was later released for the hospital. During the full replacement surgery, it was reported by a sales representative that there wasn¿t anything abnormal. The lead impedance was normal and the device was not programmed on. Device history records were reviewed for the generator and lead. There were no unresolved non-conformities, and the devices passed all specifications prior to distribution. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8637187
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #70 on: June 13, 2019, 03:13:10 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/10/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy.
 
Event Description
It was reported that the patient reported to the clinic with a fever and cellulitis around the vns generator site. A culture was taken. A review of device history records revealed that the generator was sterilized and passed quality control inspection prior to distribution. Clinic notes were later received from the surgeon. The notes indicated that the lab results form the cultures were moderate staphylococcus aureus. It was reported that the wound was much better and the erythema was essentially completely resolved. It was stated that there was still an open area and the lower part of the incision needed to be packed. The surgical notes included in the clinic notes indicated that the lead incision site was re-opened by the surgeon. No purulence or infection was observed. The incision was irrigated with gu irrigant and antibiotics were placed in the wound. The incision was closed. The generator incision was re-opened by the physician and purulent material was encountered in the pocket. The generator was removed and the portion of the lead in continuity with the generator was removed. The generator pocket was lavaged and then instilled with antibiotic irrigation. The incision was closed except for the caudal centimeter and a half of the incision, which was left open and packed with antiseptic soaked gauze. Sterile dressing was placed about the incision. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient under surgery to explant the vns electrodes, which were the only portion of the lead remaining implanted, due to the cultures coming back as (b)(6).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7050156
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #71 on: June 14, 2019, 06:06:59 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/02/2017
Event Type  Injury   
Event Description
It was reported by the patient's wife that the patient was very sick again. The patient was in the hospital for an increase in seizures and then developed a high fever. No additional relevant information has been received to date.
 
Event Description
Follow up with the physician revealed that during a visit after the reported event that the vns was noted to be working well. The physician's notes indicated that the patient's last seizure was six weeks prior to the clinic visit and there were no notes regarding the hospital, fever, or increase in seizures.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7065465
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #72 on: June 15, 2019, 11:27:09 PM »

Model Number 304-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 10/10/2017
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that this patient recently had a generator replacement, where pin insertion was checked, and lead impedance was ok at the time of replacement, but high lead impedance was observed a few days after the replacement. It was reported that the patient has experienced a significant increase in seizures that are stronger than their usual seizures. The patient also exhibits swelling on the left side of the neck as well as a low grade fever. No known surgical intervention has occurred to date.
 
Event Description
It was reported that the patient's lead was replaced. The device has not been received by the manufacturer to date. No other relevant information has been received to date.
 
Event Description
The lead has been received by the manufacturer for product analysis. Analysis is underway but has not been completed to date. No other relevant information has been received to date.
 
Manufacturer Narrative

Event Description
Lead analysis was completed. Abraded openings were noted on the outer and the inner silicone tubing where dried remnants of what appear to have once been body fluids were present within the inner and outer silicone tubing. There was corrosion observed on the connector pin and there was indication that pitting or electro-etching occurred in the vicinity of the set screw marks. There was a portion of the lead not returned for analysis so a full evaluation could not take place. The high impedance report was not verified by product analysis which could be due to the whole lead not being received. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6998994
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #73 on: June 23, 2019, 04:00:19 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/04/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that after a recent generator replacement surgery the patient now has a depressed cough reflex and an increased heart rate of about 30 bpm higher. The patient's device was checked according to the nurse and appears to be working properly. The patient's neurologist increased her settings in response to the issues. Also, after the replacement surgery the patient was hospitalized with pneumonia. No additional or relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The neurologist indicated the relationship of the depressed cough reflex to vns is unknown, and that she was unable to assess the patient's arrhythmia and pneumonia. It was noted that the patient's heart rate increased preoperatively and returned to a normal value postoperatively. Also, information was received from the patient's neurologist that the patient was hospitalized with fever, constipation, urinary retention, hypoxia, gastric paresis, and dyspnea. Follow up was performed with the neurologist regarding these events. The neurologist stated the cause of these events was unknown as the patient was hospitalized at a separate facility, and she was unable to assess the patient directly. The neurologist was informed the patient had recovered completely and was discharged from the hospital. No additional or relevant information has been received to date.
 
Manufacturer Narrative
Describe event; corrected data; supplemental mdr #1 inadvertently omitted information that was known prior to submission.
 
Event Description
The pneumonia reported on supplemental report #1 occurred before the replacement surgery and it was also noted in this report that the patient's heart rate increased pre-operatively. Since these events occurred before the replacement surgery, they will be reported on report number 1644487-2018-00290.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7171999
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #74 on: June 28, 2019, 10:44:25 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/13/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient felt warmth at the generator site and had "complications" from a fever after her vns implant surgery. Clarification was later received that the fever after implant was related to an infection at the generator site. The surgeon provided antibiotics, and no other interventions were taken. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7544730
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #75 on: July 11, 2019, 01:01:48 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/21/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient states that she is running a fever. She had a rash all over her neck incision and she took 2 benadryl. After the benadryl, the rash subsided but she had a fever. The patient's temperature was 99. 6 degrees f. A nurse mentioned that the patient was seen later and did not have a fever then. Antibiotics were prescribed for the fever but no interventions were taken for the rash. No additional relevant information has been received. 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=7708293
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #76 on: July 23, 2019, 01:00:32 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/22/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Clinic notes were received for patient's battery replacement due to low battery. It was noted that the patient had recent seizures. A screenshot was provided of the patient's device settings and it was noted that the device was at intensified follow-up indicator = yes. Upon follow up on the patient, it was reported that the patient was scheduled for replacement surgery consult as the patient had gone home for thanksgiving and was admitted to the hospital for fever and seizures then. The patient's device was replaced. It was noted that the device would not be available to be returned for analysis. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8184304
Logged
Pages: 1 2 [3]  All   Go Up
Print
Jump to: