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MAUDE Adverse Event Report

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CYBERONICS, INC. BIPOL LEAD MODEL 300   Back to Search Results
Model Number 300-20
Event Date 07/01/2007
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Reporter indicated that the vns electrodes had been "pulled out" by the patient and that there was an infection at the site of extraction. The ncp generator and lead were explanted as a result of the events. Attempts to obtain additional information from the physician have been unsuccessful to date. Product analysis was completed on the ncp generator and lead, although the electrode portion of the lead was not returned for analysis. No anomalies were identified with the generator or portion of the lead returned.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both generator and lead prior to distribution.

 
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Brand NameBIPOL LEAD MODEL 300
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
donnie welty, rn, bsn
100 cyberonics blvd.
ste 600
houston , TX 77058
(281) 228 -7200
Device Event Key879167
MDR Report Key902907
Event Key847941
Report Number1644487-2007-01316
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 07/30/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/27/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date10/31/2002
Device MODEL Number300-20
Device LOT Number1315
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/06/2007
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received07/30/2007
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/2000
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

 
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