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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 Problem Detachment Of Device Component
Event Date 04/19/2017
Event Type  Malfunction  
Event Description

It was reported that during a prophylactic generator replacement surgery, the explanted generator was found to have a detached header. The surgeon stated the generator had been implanted under the muscle so he believes that put more pressure on the generator and caused the header to break off. Review of the manufacturing records for the generator revealed no anomalies during the manufacture of the device. The explanted generator was received 05/05/2017. Analysis is underway, but has not been completed to-date. Additional relevant information has not been received to-date.

 
Manufacturer Narrative

Event description, corrected data: it was inadvertently not provided on the initial report that the pre-operative diagnostics were within normal limits. (b)(4).

 
Event Description

Pre-operative diagnostics were within normal limits. Analysis was completed for the returned generator. The reported detachment of the header was confirmed. The detachment of the generator header was most likely the result of inadequate adhesive application during manufacture. A lack of adhesive was found on the can and header.

 
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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 Key6566110
Report Number1644487-2017-03794
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 07/03/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/14/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2011
Device MODEL Number102
Device LOT Number201100
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/05/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/08/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/27/2009
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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