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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 300-30
Event Date 12/01/2010
Event Type  Malfunction  
Event Description

Further follow-up revealed that during the surgery a dual pin generator was not available. It was reported that the patient was closed and a dual pin generator was located and the patient was taken back to the operating room the same day for only generator replacement. The lead was not replaced as previously reported.

 
Manufacturer Narrative

Corrected data: new information received indicates that the lead was not explanted.

 
Event Description

It was reported by a nurse that a vns patient reported buzzing and pain in the top of his head that had occurred 3 times within the last 3 weeks of initial report. The patient reported that placing the magnet on the generator ameliorated the pain. Moreover, the patient indicated the pain was not occurring with normal stimulation and no patient manipulation or trauma was reported. The nurse further stated that a generator diagnostic tests was performed and received a low impedance warning. The patient was interrogated and the device was found to be at 0 ma. The patient was re-programmed to 1. 5/25/500/30/1. 1 then performed system diagnostics which resulted within normal limits (ok/ok/1/no). Further information from the treating nurse indicated that the patient was scheduled for complete replacement. Moreover information from a company representative indicated the patient underwent surgery as scheduled. Good faith attempts to obtain the explanted devices have been unsuccessful to date. Additional information was received from the treating neurologist indicating the cause of the buzzing was related to generator with/ or wire malfunction. Moreover, the replacement surgery was done for patient comfort according to the neurologist.

 
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Brand NameBIPOL LEAD MODEL 300
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 7705 8
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 Key1989992
Report Number1644487-2011-00200
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/06/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/03/2011
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? No
Is The Reporter A Health Professional? No
Date Manufacturer Received08/20/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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