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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 09/22/2011
Event Type  Malfunction  
Event Description

All attempts to the reporter for additional information have been unsuccessful to date.

 
Event Description

Reporter indicated the patient had vns generator and lead replacement performed on (b)(6) 2011, due to a lead discontinuity, but an actual lead fracture was not visualized during the surgery. Significant scarring of the lead was noted. The lead was removed in pieces, and was noted to be coiled behind the generator. The generator was implanted in the abdomen intentionally when the patient was 2 years old. It is believed the patient's body growth may have contributed to the suspected lead fracture. The explanted vns generator and lead have been returned and are pending product analysis.

 
Event Description

Product analysis of the explanted vns generator and lead was completed. No anomalies were identified with the generator and the generator performed per specifications. Analysis of the lead portion returned identified abraded openings on the outer and inner silicone tubing. Note that since a portion of the lead was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations typical wear and explant related observations, no additional anomalies were identified in the returned lead portions. No lead discontinuities were identified.

 
Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal a lead discontinuity. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

 
Manufacturer Narrative

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

 
Event Description

Reporter indicated a patient had high lead impedance readings with the vns. The vns was disabled and the patient was referred for x-rays and possible surgery. Attempts for further information are in progress.

 
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Brand NameBIPOL LEAD MODEL 300
Type of DeviceBIPOL LEAD MODEL 300
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
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2302139
Report Number1644487-2011-02523
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 09/22/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/20/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2001
Device MODEL Number300-20
Device LOT Number32103C
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/23/2011
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/06/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/22/1999
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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