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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 01/15/2015
Event Type  Malfunction  
Event Description

It was reported that the vns patient¿s device was tested and diagnostic results reveal high lead impedance (dcdc ¿ 7). The patient¿s device was subsequently disabled. It was noted that the patient is cognitively impaired and requires ambulatory assistance mainly on the left side which the physician believed, along with the age of the device, was the cause of the high impedance condition. The patient was referred for surgery but no known surgical interventions have occurred to date.

 
Event Description

Additional information was received that the patient underwent a generator and lead replacement surgery on (b)(6) 2015 due to prophylactic generator replacement and high impedance. The explanted generator and lead were received for analysis. When received, the generator's header was detached, but this was stated to have occurred during explant. Analysis of the explanted lead was completed. Note that the majority of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion was consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provided evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Analysis of the explanted generator has not been completed to date.

 
Event Description

Analysis of the explanted generator was completed. Visual examination confirmed that the header was detached from the pulse generator case, which is not typical in a surgical procedure. It is very likely that the header was detached from the pulse generator case during or after the explant process. This is based on the location of the tool marks observed on the pulse generator case and header. Other than the observed generator header detachment, there were no performance or any other type of adverse conditions found with the pulse generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

 
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.

 
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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 Key4494144
Report Number1644487-2015-03781
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 01/15/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/09/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/1999
Device MODEL Number300-20
Device LOT Number23672C
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/10/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/06/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/02/1999
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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