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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 05/22/2014
Event Type  Malfunction  
Event Description

On (b)(6) 2014, it was reported that this vns patient's generator was explanted on (b)(6) 2014 because the generator failed during testing. Follow-up showed that no troubleshooting was recorded in the operative note. Per the surgeon's office, the device was successfully communicated with on (b)(6) 2013 (date of implant) at which time, the device was not programmed on. The explanted generator has been returned to the manufacturer where analysis is currently underway. Review of manufacturing records confirmed that the suspect device passed all functional tests prior to distribution.

 
Event Description

The information available indicates that the exposure to electrocautery occurred at the time of explant, not implant.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

 
Manufacturer Narrative

Describe event or problem, corrected data: previously submitted mdr indicated that burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during device implant; however, this should have reflected that the exposure occurred at device explant. This report is being submitted to correct this information.

 
Manufacturer Narrative

Review of the available programming/diagnostic history and decoder data.

 
Event Description

Analysis of the returned generator was completed. A failure was noted in the output circuit of the generator to deliver a pulse between the positive and negative electrodes. The no output condition was due to a failure of the asic to deliver a pulse on the positive output pin. Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during device implant. The no output condition is possibly due to damage by the use of electro-cautery. It also noted that the battery was swollen, indicating that the generator was in a high current state at one point. Review of the available programming and diagnostic history along with the decoder data from the generator replacement procedure on (b)(4) 2013 showed that the final system diagnostic test performed that day had the pulse status as enabled, indicating that the pulse disablement likely occurred due electrocautery used during the explant procedure on (b)(4) 2014.

 
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Brand NamePULSE GEN MODEL 105
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3965041
Report Number1644487-2014-01846
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/03/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/29/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2015
Device MODEL Number105
Device LOT Number202613
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/24/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/26/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/07/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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