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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 08/28/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient was experiencing painful stimulation. The patient¿s device was tested and system diagnostic results revealed high impedance (dc dc ¿ 6). X-rays were taken and were reported by the physician to be unremarkable. No known surgical interventions have occurred to date.

 
Event Description

Product analysis for the generator was completed and approved on (b)(4) 2015. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. The output exhibited output variations on chart. This condition was due to an intermittent connection on the alligator clip, used to establish an electrical connection to the generator. The pulse generator was monitored again for more than 24-hrs and results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The reported ¿detachment of components(s)/header¿ allegation, most likely occurred during or after the explant process. This is based on the location of the tool marks observed on the pulse generator case and header. In addition, the generator as received photo shows no evidence of bodily fluid remnants in the case/header area. Therefore, this observation/finding is not considered a device failure, but instead the result of extensive manipulation of the product during or after the explant process. The generator performed according to functional specifications. Other than the intermittent connection issue that is not related to the generator and the header anomaly (visual analysis), there were no performance or any other type of adverse conditions found with the pulse generator.

 
Event Description

Product analysis for the generator that was completed on 04/16/2015 concluded that the generator detachment of components was most likely attributed to explant related events. Therefore the possibility of a lead break cannot be ruled out. The patient's lead has not been explanted to date.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death or serious injury.

 
Manufacturer Narrative

Corrected data: changed suspect device to lead.

 
Event Description

It was reported that the patient underwent generator replacement on (b)(6) 2015. It was stated that the generator was in two pieces as the header was detached from the generator. The lead was not replaced. When the new generator was attached to the old lead impedance values were good at 2825 ohms. The generator was returned for analysis on 03/19/2015. Analysis is currently underway but has not been completed to date.

 
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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 Key4115750
Report Number1644487-2014-02461
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 08/28/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/24/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2002
Device MODEL Number300-20
Device LOT Number39845C
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/19/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/25/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/07/2000
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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