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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 10/22/2014
Event Type  Malfunction  
Event Description

It was reported that during initial implant surgery, the device diagnostics were run with the generator in the pocket and resulted in vbat less than eos. It was reported that two device diagnostics performed prior to closing the generator pocket were within normal limits, but that after the generator pocket was closed the vbat less than eos message appeared. It was reported that the generator was likely exposed to electrocautery during the surgery. The surgeon replaced then replaced the generator. The explanted generator was received for analysis. Analysis is underway, but has not been completed to date.

 
Manufacturer Narrative

(b)(4). Corrected data: inadvertently did not include the udi on the initial report.

 
Event Description

Analysis of the returned generator was completed which confirmed an output pulse disabled condition due to a perceived low battery voltage. Analysis concluded that the event may be related to high energy exposure during surgery. The pulse generator performed according to functional specifications after output was re-enabled.

 
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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 Key4255773
Report Number1644487-2014-03039
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/22/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/17/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/08/2016
Device MODEL Number105
Device LOT Number4033
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/07/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/21/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/15/2014
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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