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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 03/13/2010
Event Type  Injury  
Event Description

It was initially reported that the pt would experience an "electrical shock" in her neck with device stimulation. The pt stated she placed her magnet over the device to temporarily inhibit stimulation however this made the pain worse. The physician in the er who saw the pt did not believe this issue was serious and indicated that the pt was making herself more anxious over the stimulation. The pt followed up with her neurologist who programmed her device off. The physician indicated that pain resolved once the device was programmed off. X-rays were taken and sent to the mfr for review and no obvious causes for the pain could be identified. The pt underwent a full revision due to the pain in which the lead was replaced due to a lead fracture and the generator was replaced prophylactically. The lead and generator has been returned to the mfr and product analysis is currently in process. Good faith attempts to obtain additional info are currently being made.

 
Manufacturer Narrative

Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
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Brand NameLEAD MODEL 302
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1666447
Report Number1644487-2010-00964
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/24/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/22/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2010
Device MODEL Number302-20
Device LOT Number200411
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer04/20/2010
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/24/2010
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/01/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/22/2010 Patient Sequence Number: 1
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