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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 101 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 101 GENERATOR Back to Search Results
Model Number 101
Event Date 12/15/2014
Event Type  Malfunction  
Event Description

It was reported that during generator replacement surgery high impedance (8627 ohms) was observed with the new generator and existing lead. The surgeon then replaced the lead and used a new compatible generator. The surgeon observed a small tear in the lead body near the connector pin. Further follow-up revealed that prior to replacing the lead, the surgeon confirmed that the lead pin was fully inserted into the generator header; however, the high impedance remained. It was reported that the explanting facility discards the explanted devices; therefore, no product analysis can be performed.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
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Brand NamePULSE GEN MODEL 101
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 Key4416357
Report Number1644487-2015-03606
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/15/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/14/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2001
Device MODEL Number101
Device LOT Number38308C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/15/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2000
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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