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Author Topic: Misc. Pain  (Read 16776 times)
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dennis100
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« Reply #450 on: March 16, 2019, 02:05:59 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/09/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
A physician reported to an international distributor that a patient experienced dyspnea and syncope. The physician was advised to reprogram vns settings but it is unknown if he did so or if he took any other form of intervention. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Updated information from the physician clarified that the patient experienced one brief episode of throat pain with vns stimulation which lead dyspnea. No intervention was necessary and the event has not recurred. The physician also clarified that the syncope was related to the patient's typical seizure activity and not an independent event of syncope. The physician stated that the seizure activity was not related to vns and the patient's seizure frequency has not increased. Vns function was deemed to be normal at all times with normal lead impedance observed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5125415
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dennis100
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« Reply #451 on: March 16, 2019, 02:08:51 AM »

Model Number 303-20
Device Problems Circuit Failure; Loss of Power
Event Date 09/07/2015
Event Type  Malfunction   
Event Description
It was reported that a vns patient had pain in the neck and throat, and swollen spot in the neck. It was reported that short circuit was suspected, as the dcdc value dropped from 6 to 5, to 3, to 2 and now 0. The generator was switched off. It was reported that the x-rays will be taken then sent to the manufacturer for review. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. Review of manufacturing records confirmed that both lead and generator passed all functional tests prior to distribution. No known surgical interventions have occurred to date.
 
Event Description
It was later reported that the vns patient had eating disorder, hoarseness, dysphagia and protrusion. Review of the available programming and diagnostic history received from the nurse showed normal diagnostic results through (b)(6) 2012. The x-rays were taken and sent to the manufacturer for review. The generator appears in the upper left chest in a normal placement. The filter feed-through wires appeared to be intact. The lead connector pin seems to be fully inserted into the generator connector block. The electrodes placement seems to be normal. One tie-down, strain relief bend were used to secure the implanted lead but not as indicated in the labeling. Part of the lead was behind the generator. No lead breaks or sharpe angles were visible on the assessed lead parts.
 
Event Description
Further information received indicating that the patient underwent a full revision. The lead was replaced due to lead function issue (low impedance) and the generator was replaced likely due to battery depletion. No explanted devices return is expected at ths time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5123049
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dennis100
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« Reply #452 on: March 18, 2019, 02:21:08 AM »

Model Number 103
Device Problems Generator; Loss of or Failure to Bond; Migration or Expulsion of Device ; Material Protrusion / Extrusion; Lead
Event Date 04/07/2015
Event Type  Injury   
Event Description
It was reported that the vns patient's generator had migrated under her armpit a few weeks ago and causing pain at the generator site. The generator later moved back to the original implant site but it was noted that leads were protruding at the generator and electrode sites. The patient underwent surgery on (b)(6) 2015 to reposition the device. During the procedure, the surgeon did not observe a suture securing the lead. Patient manipulation or trauma is not believed to have caused or contributed to the event.
 
Event Description
It was reported that the vns patient continued that have issues following repositioning surgery. The patient stated that her neck area was still tight and painful. She described the issue had started as a small lump in her throat but then became ¿the size of a golf ball¿ that caused pain when eating, swallowing, or moving her neck/throat. Follow-up with the surgeon¿s office revealed that the patient had a post-operative appointment on (b)(6) 2015, and no issues were noted at the patient¿s neck region. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5253695
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dennis100
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« Reply #453 on: March 18, 2019, 02:21:49 AM »

Model Number 102
Device Problem Human-Device Interface Problem
Event Date 10/23/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via voicemail message from the patient that the patient had a newer model generator implanted but was "having a lot of trouble" and "does not feel comfortable with the way things turned out". Additional information was received that the patient had a dehiscence wound at the generator site from her replacement surgery (b)(6) 2015. Additional information was received that the patient did not believe the surgeon properly closed the incision. Additional information was received that the patient is being referred for generator/lead replacement due to pain in her neck where the lead is and when she moves her head to the left or looks up. Patient has also reported difficulty eating and chewing and states that she has lost weight since implant. No known surgical interventions have occurred to date. No additional relevant information has been obtained to date.
 
Event Description
Additional information was received that the surgeon stated that everything appeared normal with the patient's implant after observing x-rays. The device had still not been turned on as of (b)(6) 2015. No additional relevant information has been obtained to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5250260
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dennis100
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« Reply #454 on: March 19, 2019, 01:46:16 AM »

Model Number 302-20
Device Problem High impedance
Event Date 10/22/2015
Event Type  Malfunction   
Event Description
It was reported by a physician that a patient's vns showed high lead impedance on diagnostics at a clinic visit. Additional relevant information has not been received to-date. No known surgical intervention has occurred to-date.
 
Event Description
Follow-up to the physician revealed a chest x-ray was taken and showed that the device migrated down near the left breast and medial to the original location. The x-rays were not sent to the manufacturer for review. The patient reported the migration had occurred over the past three years. The patient reported pain due to the migration which was explained by the physician as mechanical from the patient's bra rubbing on the unit. The last systems diagnostics in (b)(6) 2015 were reportedly fine. The physician did not know whether the sutures were non-absorbable or the relationship of the sutures to the migration. It was reported the patient has not had any significant changes in weight. The physician believes that the high impedance and the migration are related and that the high impedance is the result of the migration of the generator. The device was not turned off, and the settings were not changed.
 
Event Description
Operative notes for the implant surgery were received and indicated that a stitch was used to secure the generator, but the type of suture was not indicated. For the lead, two loops were formed and were stated to be secured with stitches. The type of suture used to secure the loops of the lead was not indicated.
 
Event Description
Clinic notes from a visit on (b)(6) 2016 were received providing that the patient had her generator disabled on (b)(6) 2016 due to discomfort, however she experienced an increase in frequency and more violent seizures since it was turned off. The patient had the device turned back on (b)(6) 2016. Diagnostics on (b)(6) 2016 showed high lead impedance. Follow-up to the physician revealed that the additional discomfort was experienced in the neck due to stimulation and resolved after the device was turned off. The pain at the chest was specified to be in the left superior chest and did not resolve after the device was turned off. Re-enabling the device did not resolve the increase in seizures.
 
Event Description
An implant card was received 05/24/2016 indicating the generator was replaced prophylactically and the lead was replaced due to lead discontinuity. The explanted devices were reported to have been discarded and are unable to be returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5237219
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dennis100
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« Reply #455 on: March 19, 2019, 01:46:58 AM »

Model Number 304-20
Device Problem Insufficient Information
Event Date 07/13/2015
Event Type  Injury   
Event Description
On (b)(6) 2015 the patient reported that her voice alteration, which she stated is not related to vns stimulation, has progressed since surgery to the point where she believes she has, at a minimum, partial vocal cord paralysis. The patient noted she also has severe pain when trying to speak. It was previously reported on (b)(6) 2015 that the patient experienced voice alteration and dyspnea following implant surgery on (b)(6) 2015. The patient went to the emergency room and received anti-inflammatories and albuterol. The issues resolved, and it is planned to turn on the vns on (b)(6) 2015. The patient later reported that she still has not yet gotten her voice back and since receiving vns she has been experiencing nausea while eating and it feels like there is "air in her chest". Good faith attempts for further information were unsuccessful.
 
Manufacturer Narrative
(b)(4). Corrected data: inadvertently did not include the suspect device udi on the initial report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5242672
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dennis100
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« Reply #456 on: Today at 11:18:48 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/02/2013
Event Type  Injury   
Event Description
Clinic notes were received indicating that the vns patient had been experiencing pain at both the generator and lead sites since initial implant and before the device was even programmed on. The device was checked and device settings were increased during the office visit and the patient tolerated the procedure well. Additional information was received stating that the patient passed out due to pain on (b)(6) 2015. Following device disablement on (b)(6) 2015, the patient has not reported any further pain and syncope events and does not have a history of syncope. The patient device was tested and diagnostic results showed normal device function. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Event Description
Follow-up revealed that the painful stimulation was occurring in the left neck.
 
Event Description
Additional information was received from the patient stating that despite device disablement, the patient was still experiencing pain in his neck when moving his head/neck and that there was swelling at his neck/shoulder area.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5208395
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