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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
Event Date 03/31/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that diagnostic tests were taken on the generator prior to implanting of device outside of the pocket and after device was in the pocket. The test before implant showed the battery was not at near end of service condition, but the test after the generator was in the pocket showed that the device was at end of service condition. It was reported that the generator was not cold prior to implant. The physician decided to continue implanting the generator. The manufacturer's or specialist that attended the surgery did not see cautery come in contact with the generator, but the cautery device was lying on the patient when the generator was introduced. The surgeon also submerged the generator in a tray with antibiotic solution prior to implant. The manufacturer investigated the programming data available from surgery. The voltage dropped from 3. 287v to 1. 884v during the surgery. The initial interrogation (before implant) and system diagnostics were at ifi = no, and the subsequent diagnostics (after implant) measured between 1. 884v and 1. 988v. The drop in voltage is an indicator that the device likely came in contact with an electro-cautery device or an electrostatic discharge, causing the asic latch-up condition. Electro-cautery is known to potentially cause battery depletion and its usage is warned against in labeling. No known surgical intervention has occurred to date.

 
Event Description

It was reported that this patient's generator was replaced, and the explanted generator was discarded after surgery. No other relevant information has been received to date.

 
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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 Key5594516
Report Number1644487-2016-00851
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Report Date 10/17/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/21/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/27/2017
Device MODEL Number103
Device LOT Number203335
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/26/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/10/2015
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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