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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 05/02/2013
Event Type  Malfunction  
Event Description

It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed high impedance and a near end of service condition. The patient¿s device was subsequently disabled. The patient underwent generator and lead replacement surgery on (b)(6) 2014. Pre-operative diagnostics still showed high impedance. Prior to replacement, the lead pin was reinserted into the generator header but the high impedance did not resolve. The explanted generator and lead have not been returned to date.

 
Event Description

The patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanted generator and lead were returned to the manufacturer for analysis. There is no evidence to suggest discontinuities in the returned portions of the lead which may have contributed to the reported high impedance. The abraded openings found on the outer silicone tubing most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed and no discontinuities were identified. Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Analysis of the returned generator is currently underway.

 
Event Description

Analysis of the generator was completed on 10/24/2014. There were no performance or any other type of adverse conditions found with the pulse generator. The generator decoder identified that the lead impedance changed from 5657 ohms to 12700 ohms on (b)(6) 2013.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury. Describe event or problem; corrected data: the initial mdr inadvertently provided an incorrect date for the replacement surgery. Explant date; corrected data: the initial mdr inadvertently provided an incorrect date for the replacement surgery.

 
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Brand NameBIPOL LEAD MODEL 300
Type of DeviceLEAD
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4122749
Report Number1644487-2014-02495
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 08/27/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/26/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2001
Device MODEL Number300-20
Device LOT Number29559C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/24/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/13/1999
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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