Pages: [1] 2 3 ... 10
 1 
 on: January 15, 2019, 03:40:37 AM 
Started by dennis100 - Last post by dennis100
Model Number 302-20
Event Date 01/01/2013
Event Type  Injury   
Event Description
It was reported that clinic notes on (b)(6) 2013 note that device diagnostics were within normal limits. The patient's wife indicated that vns therapy did not help the patient and that the patient's arm was sore near the implant site. The patient requested to have the vns explanted.
 
Manufacturer Narrative

Event Description
It was reported that the explanted devices are not available for return to the manufacturer for analysis.
 
Event Description
It was reported that the vns patient underwent surgery on (b)(6) 2013 to explant his generator and lead due to a painful lead pulling sensation on the left side of his neck. The patient¿s device had previously been disabled in (b)(6) 2013 due to lack of efficacy. The painful lead pulling sensation continued with the device disabled. The generator and lead were explanted because the presence of the device was causing the pain and the patient never received efficacy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3813078

 2 
 on: January 15, 2019, 03:39:38 AM 
Started by dennis100 - Last post by dennis100
Model Number 302-30
Event Date 04/25/2014
Event Type  Malfunction   
Manufacturer Narrative
Date of event; corrected data: additional information indicates that the date of event was (b)(6) 2014.
 
Event Description
It was reported that the vns patient was referred for surgery due to high impedance and end of service. No known interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2010.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received indicating that the vns patient was tested multiple times during an office visit on 04/25/2014 and diagnostic results revealed high impedance (impedance value >= 10,000 ohms). The neurologist was unaware of any trauma that may have caused or contributed to the reported high impedance. The patient was referred for surgery but the patient declined replacing her device. According to the patient¿s husband, the patient never received efficacy with vns. The husband stated that the patient had been seizure free for two months using a new medication. According to the neurologist, there was no lack of efficacy with vns for the patient. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3826482

 3 
 on: January 15, 2019, 03:36:54 AM 
Started by dennis100 - Last post by dennis100
Model Number MODEL 250
Event Date 04/16/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that during interrogation of the patient¿s device it was observed that the patient¿s settings were different than what was programmed at the previous office visit. During review of the in-house programming/diagnostic history database, it was observed that on office visit on (b)(6) 2014 the patient's settings were different than what were programmed at the previous office visit on (b)(6) 2014. The settings found were indicative of a faulted diagnostic test which occurred on (b)(6) 2014. The device was not interrogated prior to the patient leaving the office on (b)(6) 2014 as recommended by device manufacturer to ensure the device is at the correct settings; therefore, the settings were not corrected prior to the patient leaving the office. The settings were corrected on (b)(6) /2014. No patient adverse events were reported.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3821810

 4 
 on: January 15, 2019, 03:35:55 AM 
Started by dennis100 - Last post by dennis100
Model Number MODEL 250
Event Date 03/10/2009
Event Type  Malfunction   
Event Description
During review of programming and diagnostic history, it was observed that an interrupted system diagnostic test occurred that caused an unintended change in device settings during an office visit on (b)(6) 2009. The physician corrected the settings; however, the output current was not corrected. No patient adverse events were reported.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3813071

 5 
 on: January 15, 2019, 03:35:21 AM 
Started by dennis100 - Last post by dennis100
Model Number MODEL 250
Event Date 04/14/2007
Event Type  Malfunction   
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
During review of programming and diagnostic history, it was observed that an interrupted system diagnostic test occurred that caused an unintended change in device settings during implant surgery on (b)(6) 2007. No patient adverse events were reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3824798

 6 
 on: January 15, 2019, 03:33:24 AM 
Started by dennis100 - Last post by dennis100
Model Number MODEL 250
Event Date 08/09/2013
Event Type  Malfunction   
Manufacturer Narrative
This information was inadvertently left off of initial mfr. Report.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
During review of the in-house programming/diagnostic history database, it was observed that on office visit on (b)(6) 2013 the patient's settings were indicative of a faulted diagnostic test. There was no previous history available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3821815

 7 
 on: January 15, 2019, 03:32:32 AM 
Started by dennis100 - Last post by dennis100
Model Number MODEL 250
Event Date 03/30/2014
Event Type  Malfunction   
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
During review of programming and diagnostic history, it was observed that an interrupted generator diagnostic test occurred that caused an unintended change in device settings during an office visit on (b)(6) 2014. The physician corrected the settings; however, the magnet output current and magnet on-time were not corrected. No patient adverse events were reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3813070

 8 
 on: January 15, 2019, 03:30:07 AM 
Started by dennis100 - Last post by dennis100
Model Number 304-20
Event Date 04/24/2014
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer reviewed ct scans of implanted device. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Ct scans reviewed by manufacturer, unable to assess lead continuity or lead pin insertion. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the vns patient's device was disabled on (b)(6) 2014. X-rays were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. Due to the poor quality of the images, lead pin insertion and the filter feed-through wires cannot be assessed. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the high lead impedance remains unknown.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.
 
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed high lead impedance (dc dc - 7). The patient¿s device was not programmed off following the high impedance observation. Ct scans were provided to the manufacturer for review but were unable to determine the integrity of the lead and whether the lead pin was fully inserted into the generator header. The last known good system diagnostic results were from the date of implant. Patient manipulation or trauma is not believed to have caused or contributed to the high impedance. Further follow-up revealed that the implant surgeon hit the patient¿s jugular as he tunneled from chest to neck. The patient was seen 15 days after implant surgery and presented with severe voice hoarseness. The patient¿s device was programmed on during an office visit on (b)(6) 2013. During the office visit on (b)(6) 2014, the patient¿s device settings were increased. A diagnostic test was subsequently performed and a warning message appeared indicating high impedance and limited output current. The neurologist misinterpreted the diagnostic results and increased the patient¿s device settings. A second diagnostic test was performed which revealed the high lead impedance. It was reported that the patient was doing well. No known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3823884

 9 
 on: January 15, 2019, 03:26:31 AM 
Started by dennis100 - Last post by dennis100
Model Number 302-20
Event Date 04/15/2014
Event Type  Malfunction   
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The patient underwent revision surgery. Follow-up with the implant facility revealed that the explanted product was discarded following surgery.
 
Manufacturer Narrative
Explant date; corrected data: additional information indicates that the suspect device was explanted on (b)(6) 2014. Evaluation codes, conclusions; corrected data: additional information indicates that the suspect device was explanted on (b)(6) 2014. It is unknown if the explanted device was explanted.
 
Event Description
Additional information was received stating that the patient¿s generator was replaced on (b)(6) 2014. The patient¿s lead was not replaced at this time. The patient underwent lead replacement surgery on (b)(6) 2014. The explanted lead has not been returned to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
The explanting facility discarded the explanted device; therefore, no analysis can be performed.
 
Event Description
Clinic notes were received indicating that the vns patient¿s device was tested and system diagnostic results showed high lead impedance (dc dc ¿ 4). Subsequent normal and system diagnostics showed lead impedance within normal limits (dc dc ¿ 3). The patient reported that she noticed a change with her device. The patient was no longer able to perceive stimulation or voice alteration two days prior to the office visit on (b)(6) 2014. The patient also reported having hypoesthesia at her neck. No medication changes or programming changes occurred that could have caused or contributed to the hypoesthesia or decreased perception of stimulation. The patient reported no trauma related to the event. The neurologist stated that the patient¿s issues were due to battery depletion despite diagnostics showed eri = no. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. The notes indicate that the patient's device could not be interrogated during an office visit on (b)(6) 2013 so no diagnostic results were performed at that time. A battery life calculation using the available programming history showed approximately 3. 68 years until eri = yes. No known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3816311

 10 
 on: January 15, 2019, 03:24:56 AM 
Started by dennis100 - Last post by dennis100
Model Number 302-20
Event Date 01/01/2013
Event Type  Injury   
Event Description
It was reported that clinic notes on (b)(6) 2013 note that device diagnostics were within normal limits. The patient's wife indicated that vns therapy did not help the patient and that the patient's arm was sore near the implant site. The patient requested to have the vns explanted.
 
Manufacturer Narrative

Event Description
It was reported that the explanted devices are not available for return to the manufacturer for analysis.
 
Event Description
It was reported that the vns patient underwent surgery on (b)(6) 2013 to explant his generator and lead due to a painful lead pulling sensation on the left side of his neck. The patient¿s device had previously been disabled in (b)(6) 2013 due to lack of efficacy. The painful lead pulling sensation continued with the device disabled. The generator and lead were explanted because the presence of the device was causing the pain and the patient never received efficacy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3813078

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