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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 104 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Event Date 05/08/2012
Event Type  Malfunction  
Event Description

It was initially reported that a vns patient underwent a full revision surgery due to an unknown reason. During the surgery, the surgeon elected to not remove the patient's previously implanted m302 lead and implant a new m304 lead on the right vagus nerve. Instead of utilizing a generator model that was compatible with the new lead, the surgeon opted to implant a dual pin m104 generator (on the left side of the chest) by inserting the single lead pin into one of the two connector blocks. As expected, subsequent diagnostic testing resulted in high impedance results and the patient has reportedly received no efficacy from therapy since the surgery. Additionally, the patient has expressed the presence of neck pain as a result of the lead extending from the left chest to the right side of the neck. The reported high impedance issue is a result of the incorrect implantation technique which has created an open circuit in the system, and not the result of a device malfunction. This is not an unexpected performance of the device, given the implant circumstances. Additionally, product compatibility is clearly listed in product labeling. Additional information from the area representative indicated the patient underwent generator replacement surgery for a single pin generator. Impedance value after replacement was ok. The explanted device will not be returned to the manufacturer for analysis.

 
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Brand NamePULSE GEN MODEL 104
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
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2592674
Report Number1644487-2012-01354
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/09/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/30/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2012
Device MODEL Number104
Device LOT Number2788
Was Device Available For Evaluation? No
Event Location Other
Date Manufacturer Received05/09/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2010
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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