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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

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CYBERONICS, INC. BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Event Date 07/15/2011
Event Type  Malfunction  
Event Description

It was reported to the mfr via an implant card that a vns pt underwent both generator and lead replacement due to a lead break. Further info was received from the area representative indicating that the pt had reported pain in the chest area. The surgeon opened the pt to have a look at the pain and saw liquid inside the electrodes. A full revision was then planned and the pt was explanted. Additional info was received from the pt's treating physician indicating that the pt introduced himself in their outpatient department in (b)(6), telling he suffered from increasing pains in the subcutaneous pectoral area. Wounds were non-irritating as well as the wound on his throat and the conduction lines of the stimulator lead. The skin on the subcutaneous pectoral implantation area was hard showing the indication of scarring. After further discussion with other physicians, it was decided to operate on the pt. The physician described "there was a subtle preparation of the lead of the vagus nerve stimulator, showing that the case around the lead was damaged and there is liquid between the silicone case and he lead. " at the moment it was indicated that the lead was discarded but the generator will be returned to the mfr. Good faith attempts to obtain additional info have been unsuccessful to date.

 
Manufacturer Narrative

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

 
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Brand NameBIPOL LEAD MODEL 300
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
suite 600
houston , TX 77058
2812287200
MDR Report Key2245743
Report Number1644487-2011-01971
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/25/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/24/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2005
Device MODEL Number300-20
Device LOT Number8010
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/25/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2003
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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