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Author Topic: Lost/Stolen  (Read 1515 times)
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dennis100
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« Reply #30 on: December 20, 2018, 01:32:26 AM »

Model Number 103
Event Date 12/19/2014
Event Type  Injury   
Event Description
Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. On 03/11/2015 it was reported that the physician lacerated the carotid artery of the patient during the re-implant surgery. A vascular surgeon was called in to assist. After 7 hours, the patient appeared to be stable and was sent to the icu to stay the evening.

Event Description
It was reported that the patient developed an infection at the generator site and would undergo generator explant. It was reported that the surgeon would clean the generator pocket and then making a new generator pocket and implanting another generator. It was later reported that the patient presented to surgery with a badly infected generator pocket with an open wound and the generator missing. It was reported that the lead was sticking out of the pocket with the lead pins torn off. It was presumed that the lead pins were still connected to the missing generator. The surgeon decided to explant the lead and let the mrsa infection heal before re-implanting in 2-4 weeks. It was reported that the patient did not know what happened to the generator. The surgeon indicated that the chest wound broke down and extruded. The patient initially had a seroma, but that the generator eventually extruded through the skin. No additional relevant information has been received to date.

Manufacturer Narrative

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4532501
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dennis100
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« Reply #31 on: January 01, 2019, 04:41:28 AM »

Model Number MODEL 250
Event Date 10/01/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013, the physician complained that he was having intermittent communication issues with various patients using the programming system and screen freezes that were resolved with resets. It was not clear when the screen freezes would occur. The physician was said to be "fed up" and wanted a new system. Per the physician, the issue was occurring for a few months; however, it was not previously reported to the manufacturer. Review of the device history records indicate no unresolved non-conformance issues were present. The physician was sent a new programming system. No other information has been provided.
 
Event Description
The handheld and related software/flashcard is unable to be located. Therefore, it is lost and will not be returned to cyberonics.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3554857
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dennis100
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« Reply #32 on: January 09, 2019, 08:29:24 AM »

Model Number MODEL 250
Event Date 02/10/2014
Event Type  Malfunction   
Event Description
It was later reported that the site no longer has the handheld and that it appears to have been lost. The physician could not recall any specifics about the problems he was having with the handheld.
 
Event Description
It was reported by the neurologist that he was having problems with his handheld. Troubleshooting was performed but was unsuccessful. The neurologist had to use his partner¿s handheld to complete the appointment.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3674085
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dennis100
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« Reply #33 on: January 15, 2019, 01:21:06 AM »

Model Number MODEL 250
Event Date 04/23/2014
Event Type  Malfunction   
Event Description
The programming tablet is expected to be returned to manufacturer for analysis, but has not been received to date.
 
Event Description
It was reported that the neurosurgeon¿s tablet device could not be connected to the programming wand because the connection had been stripped and was no longer tight. The tablet device is expected to be returned to the manufacturer but has not been received to date.
 
Event Description
On (b)(6) 2014, it was reported that an exhaustive search of the reporting facility was unsuccessful in locating the suspect medical device. The device is not expected for return at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3821329
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dennis100
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« Reply #34 on: January 19, 2019, 02:33:16 AM »

Model Number MODEL 250
Event Date 05/13/2014
Event Type  Malfunction   
Manufacturer Narrative
The handheld cannot be located and therefore will most likely not be returned.
 
Event Description
Additional information received revealed that the handheld cannot be located and therefore it is unlikely that the handheld and associated flashcard will be returned for analysis.
 
Event Description
It was reported that the neurologist was having issues with his handheld device. When attempting interrogation, the interrogation progress bar would appear but never successful completed the interrogation. The handheld device would not go past the interrogation successful screen. The programming wand was used with a tablet device and was able to successfully perform interrogations. The hard reset was performed on the handheld device but the issues were not resolved. The handheld device and software flashcard have not been returned to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3855669
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dennis100
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« Reply #35 on: January 20, 2019, 01:14:09 AM »

Model Number MODEL 250
Event Date 01/14/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
On (b)(6) 2014, it was reported that the physician's handheld was showing an error that the flashcard is unable to be recognized. A hard reset was performed, but the error showed up right after the dell screen. The flashcard was removed, and it was observed that a few of the pins in the flashcard slot were visibly bent. Attempts have been made for additional information; however, they were unsuccessful. No other information has been provided.
 
Manufacturer Narrative
Manufacturer reviewed device history records. Review of the handheld device history records confirmed all quality specifications were passed prior to distribution.
 
Event Description
The physician's office reported that they no longer have the handheld device, and the location/disposition of the device is unknown.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3623251
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dennis100
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« Reply #36 on: January 23, 2019, 01:47:08 AM »

Model Number MODEL 250
Event Date 06/10/2014
Event Type  Malfunction   
Event Description
It was reported that there were communication issues with the programming system. The wand battery was replaced and the handheld was unplugged from the wall socket. The communication issues resolved when the serial cable was held in a specific orientation. The handheld serial cable has not been returned to date. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Manufacturer Narrative
Describe event or problem, corrected data: previously submitted mdr omitted that the new serial cable did not resolve the issue.
 
Event Description
The products are not expected for return as they are believed to be lost.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3913621
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dennis100
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« Reply #37 on: January 24, 2019, 03:39:20 AM »

Model Number 105
Event Date 07/30/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the generator confirmed all quality tests were passed prior to distribution.
 
Event Description
It was reported that during generator implant, the rubber septum plug over the set screw popped out when the surgeon was tightening the set screw. It was reported that the plug fell out of the sterile field. The plug was unable to be located within the or and a new generator was implanted. It was reported that the physician did not use any excessive force that may have caused the plug to come off. It was reported that the plug popped out easily as if it was not attached. The generator was returned for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Analysis of the returned generator was completed. There were no adverse functional, mechanical, or visual issues identified with the returned generator. No signs of manipulation of the returned setscrew were present and the septum was not returned for evaluation. The header septum cavity meets specification. Therefore, a root cause for the condition could not be determined. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4042354
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dennis100
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« Reply #38 on: January 30, 2019, 08:56:25 AM »

Model Number MODEL 250
Event Date 08/18/2014
Event Type  Malfunction   
Event Description
Additional information was received indicating that the replacement serial cable had solved the reported programming issues. The suspect serial cable was lost; therefore, no analysis can be performed.
 
Event Description
It was reported that the physician's handheld was having intermittent trouble and that it would sometimes interrogate patient's generators and sometimes it would not. Additionally, it was reported that occasionally device diagnostics would not complete. A known working wand was connected to the handheld and the problem persisted indicating a possible handheld or handheld serial cable issue. It was reported that the message "failure to receive all bytes in sequence message" was seen. The physician has several programming systems and no patient's were affected by this issue. A new serial cable was provided to the physician. No additional relevant information has been received to date. The serial cable is expected to be returned for analysis, but has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4089126
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dennis100
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« Reply #39 on: February 06, 2019, 01:27:02 AM »

Model Number 302-20
Event Date 08/01/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results revealed high impedance (impedance value = 10,000 ohms). A few months prior to the observed high impedance condition, the patient was experiencing shocking sensations at his neck which had recently resolved. No known surgical interventions have occurred to date. X-rays were taken and were reported by the physician to be unremarkable. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. 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.
 
Event Description
Additional information was received stating that the vns patient underwent surgery on (b)(6) 2015 to explant his device. The patient¿s family elected not to replace the system as the patient had been seizure-free for over a year. The explanting facility misplaced the explanted devices and was unable to return the devices to the manufacturer; therefore, no analysis can be performed.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4348113
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dennis100
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« Reply #40 on: February 14, 2019, 01:06:58 AM »

Model Number TABLET MOT
Event Date 03/04/2015
Event Type  Malfunction   
Event Description
Information was received from a company representative on 05/14/2015 that the cable is lost and will not be returned. The replacement cable resolved the issue.
 
Manufacturer Narrative

Event Description
It was reported that the physician's tablet usb cable was not working. A replacement cable was provided to the physician. The malfunctioning usb cable is expected to be received for analysis, but has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4641096
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dennis100
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« Reply #41 on: February 14, 2019, 01:07:55 AM »

Model Number TABLET MOT
Event Date 03/06/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the physician's office is unable to locate the tablet usb serial cable at this time. The cable has not been received to date.
 
Event Description
It was reported that the nurse practitioner's tablet was giving an "unable to open port" error message. A new usb cable was provided to the nurse practitioner. The malfunctioning usb cable is expected to be returned for analysis, but has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4645343
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dennis100
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« Reply #42 on: February 14, 2019, 01:08:57 AM »

Model Number MODEL 250
Event Date 03/03/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Information was received from a company representative on (b)(6) 2015 that the tablet serial cable is lost and will not be returning to the manufacturer for analysis.
 
Event Description
It was reported that the company representative's programming system was unable to program a patient's device off. Troubleshooting was performed which identified that the programming wand was not functioning. The company representative was provided a new programming wand and the nonfunctional wand was received for analysis. It was later reported that the issue remained with the new programming wand. The company representative indicated that the "unable to open port" error message was still being received indicating a possible problem with the usb cable that connects the wand and tablet. The company representative was provided a new usb cable. The nonfunctional usb cable is expected to be returned for analysis, but has not been received to date. Analysis of the programming wand was completed on 03/26/2015. No visual or mechanical anomaly was identified. Continuity testing of the serial data cable and the battery cable passed. The programming wand performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4638077
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dennis100
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« Reply #43 on: Today at 01:06:25 AM »

Model Number 102
Event Date 10/04/2013
Event Type  Injury   
Event Description
On (b)(6) 2013, it was reported that the explanted devices cannot be returned for product analysis as the hospital could not locate them.
 
Manufacturer Narrative

Event Description
On (b)(6) 2013 it was reported that the patient had the vns generator and lead explanted on (b)(6) 2013 due to the patient lack of efficacy and pain at the sites. Attempts were made for additional information; however, they were unsuccessful. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3444251
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