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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Device Problems Device Displays Incorrect Message ; Battery Problem
Event Date 01/19/2015
Event Type  Malfunction  
Event Description

It was reported that during generator replacement surgery on (b)(6) 2015, the vns patient¿s replacement device was implanted and programmed on to previous device settings. The patient¿s device was then tested and showed a near end of service condition. Electrocautery was not used during the procedure. Pre-operative diagnostic results of the replacement generator showed ok battery status. The patient¿s device was tested again the next day and showed pulsedisabled due to ¿vbat

 
Event Description

Additional information was received that at the follow up visit on (b)(6) 2015 the battery was showing 100% of charge; on the (b)(6) 2015 that battery was showing 30% of charge remaining. Review of the decoder data provided showed on the interrogation on (b)(6) 2015 the battery voltage (vbat) was 3. 545volt; however the "pulse disabled" incorrectly showed vbat< eos threshold which was not the case as the currently measured vbat 3. 545v is > to 2. 0v. The battery status indicator is 100%, in line with the measured vbat 3. 545v. On the next programming step on (b)(6) 2015, the measured voltage was the same, vbat 3. 545v with "pulsedisabled" showing "enabled" with no eos flag. No further eos flag showed on the next visits.

 
Event Description

Further information was received indicating that the patient underwent revision surgery on (b)(6) 2015. It was reported that the generator was explanted due to device failure. The explanted generator was returned to the manufacturer on 12/15/2015. Analysis is underway but it has not been completed to date.

 
Event Description

Analysis was completed on the explanted generator and shows a pulse disabled condition had occurred and confirms the pulse generator was programmed out of the event on (b)(6) 2015 (implant (b)(6) 2015). The battery, 2. 701 volts as measured during completion of test parameter (measured diagvbat) of the final electrical test, shows an ifi=yes condition. The data in the diag accum consumed memory locations revealed that 18. 203% of the battery had been consumed. A battery life calculation resulted in 4. 9 (minimum 4. 0) years remaining before the near-end-of-service (neos) flag would be set to a neos=yes condition. Other than the noted event (pulse disabled), there were no performance or any other type of adverse condition found with the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device implant, which may have been a contributing factor for the hardware reset condition. No device failure found during product analysis, the premature end of life condition was confirmed by product analysis as due to the pulse disabled event from an electro-cautery tool usage at implant.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key4519027
Report Number1644487-2015-03843
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 01/19/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/16/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2015
Device MODEL Number103
Device LOT Number3710
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/15/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/12/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/21/2013
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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