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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Device Problems Detachment Of Device Component; High impedance
Event Date 10/23/2017
Event Type  Malfunction  
Event Description

It was reported from an implant card that the patient had a full replacement. It was reported that the replacement was due to high impedance ¿intraoperative broken connection between battery and lead. ¿ clarification was provided through pictures received that the header was detached from the generator. System diagnostics prior to the replacement were not available. It was stated that the reason for the generator replacement was due to the high impedance and that at break was not viewable on x-ray. The detachment of the header from the generator was stated to be seen after the surgeon opened the pocket at surgery. The surgeon does not know the reason for the damage to the header. The explanted lead and generator have not been received for analysis to date.

 
Event Description

Per the physician, the explant devices were returned but have not been received by the manufacturer to date. It appears as though the device may have been lost in transit. No additional or relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 102
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 Key7045406
Report Number1644487-2017-04833
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 05/30/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/20/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2011
Device MODEL Number102
Device LOT Number201210
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/18/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/08/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/23/2017
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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