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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 08/08/2012
Event Type  Malfunction  
Event Description

It was reported that a vns patient was going to be scheduled for a battery replacement for eos. An x-ray was taken, but not sent to the manufacture for review. It was reported that "radiology report came back and stated that there is a fracture of one of the electrodes". At this time no surgery is planned but may be scheduled at a later date. No further information has been attained at this time.

 
Event Description

Additional information was received that there was no surgery date set at this time. The patient does have a history of falls, but it was unknown if they had a fall prior to their lead break. X-rays will not be provided to the manufacturer for review. No previous diagnostics are available for review.

 
Event Description

The patient had full revision surgery. No lead break was observed in the surgery. The patient's old electrodes were not removed. A portion of the lead body and explanted generator is being returned for analysis.

 
Manufacturer Narrative

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

 
Event Description

Product analysis was completed on the returned lead and generator. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Analysis was completed on their explanted generator. During the analysis, there was no indication from the device that an end of service condition existed. A battery life estimation resulted in 4. 17 years remaining before the eri flag would be set. However, an incomplete programming history (last 6 years are missing) indicates the estimation does not use all the data required to make an accurate estimation. The device performed according to functional specifications of the current automated final test. Analysis of the generator in the lab concluded that no abnormal performance or any other type of adverse condition was found.

 
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 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 herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2736900
Report Number1644487-2012-02262
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/14/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/10/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2005
Device MODEL Number300-20
Device LOT Number8434
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/05/2012
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date09/10/2012
Event Location Other
Date Manufacturer Received01/08/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/12/2003
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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