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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON BIPOL LEAD MODEL 200

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CYBERONICS - HOUSTON BIPOL LEAD MODEL 200 Back to Search Results
Model Number 300-30
Device Problem Corroded
Event Date 01/01/2018
Event Type  Malfunction  
Event Description

It was reported that the patient stated that device did not work for him and the patient did want to replace the battery. Follow up with the physician's office revealed that the vns did not change to patient's seizure frequency. The patient did not elect to replace the vns. However, the patient was referred for and underwent full vns replacement surgery due to an end of service condition and the lead compatibility with the new generator. The explanted lead was received by the manufacturer. Lead product analysis is completed. The lead assembly was returned in four portions. What appeared to be rust-like deposits and pitting were observed on the unmarked connector pin surface. Set-screw marks were observed and indicated that proper mechanical contact was present. Scanning electron microscopy, or sem, was performed and identified evidence of pitting and surface irregularities. Continuity checks of the returned lead portions were performed with no discontinuities identified. Based on the findings in the pa lab, there is no evidence to suggest an anomaly with the returned portions of the lead. No additional relevant information has been received to date.

 
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Brand NameBIPOL LEAD MODEL 200
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7923517
Report Number1644487-2018-01735
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 10/01/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/01/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number300-30
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/21/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/17/2018
Was Device Evaluated By Manufacturer? Yes
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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