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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 07/19/2014
Event Type  Malfunction  
Event Description

It was reported that the patient's generator was interrogated and found to be at 0ma. It was reported that the patient was not intentionally programmed to 0ma. Multiple system diagnostics were performed which showed lead impedance - ok and output current - low. It was reported that the generator was programmed back on successfully. Attempts to obtain additional relevant information have been unsuccessful to date.

 
Event Description

The explanted generator and lead were returned to the manufacturer for analysis. The generator performed according to functional specifications. There were no anomalies found with the pulse generator. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing on the. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portions. Incisions in the silicone tubing of the lead were necessary to perform proper inspection. Abraded openings were noted on the outer tubing and a cut opening was noted in outer tubing at the lead body. A coil discontinuity was identified in the negative coil in the vicinity of the area where a suspected break was noted. Visual examination of the lead and coil at this location show that the coil was cut. The time at which the cut occurred cannot be determined. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death or serious injury.

 
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Brand NamePULSE GEN MODEL 103
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 Key4027389
Report Number1644487-2014-02047
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/23/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/21/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2013
Device MODEL Number103
Device LOT Number201958
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/29/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/29/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/22/2011
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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