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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
Device Problem Battery Impedance Issue
Event Date 05/01/2009
Event Type  Malfunction  
Event Description

Reporter indicated that high lead impedance readings were obtained during a follow up office visit following a generator revision surgery. The physician indicated that the pt did not have issues with high lead impedance prior to the date of the report and the diagnostic testing performed twice resulted in high lead impedance. Add'l info received from a company representative who was present during the generator revision surgery revealed that diagnostics were performed on the newly implanted generator and stated that high lead impedance readings were initially received; however, once the connector pin was reinserted the high lead impedance readings resolved. X-rays were taken and sent to the manufacturer for analysis; however, the quality of the images was not ideal. No anomalies were observed; however, the entire lead could not be viewed. This info was shared with the physician's office. It is likely that the pt will undergo revision or exploratory surgery to further investigate the issue; however, no date has been set.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, 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 Key1471775
Report Number1644487-2009-01255
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/01/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/18/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2005
Device MODEL Number302-20
Device LOT Number8996
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/01/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2003
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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