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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON BIPOL LEAD MODEL 300

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CYBERONICS - HOUSTON BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Device Problem Device Contamination with Body Fluid
Event Type  Malfunction  
Event Description

A patient underwent generator replacement surgery due to battery depletion, and had their leads replaced prophylactically so that they could be compatible with the latest generator models. The explanted devices were returned for analysis. Analysis of the returned lead segments indicated dried remnants of what appeared to have once been body fluids inside the inner and outer silicone tubing. Abraded openings were noted on the inner and outer silicone tubing of the returned lead portion. The abraded openings appeared to have most likely provided the leakage path for the dried remnants mentioned. Other than the inner and outer tubing abrasions and typical wear and explant related observations, no other anomalies were identified in the returned lead portions. Analysis of the returned generator identified no anomalies. No further relevant information was received to date.

 
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Brand NameBIPOL LEAD MODEL 300
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 Key8213263
Report Number1644487-2019-02404
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 01/03/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/03/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/23/2002
Device MODEL Number300-20
Device LOT Number1285
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/01/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/12/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/03/2000
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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