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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103 LEAD

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CYBERONICS - HOUSTON PULSE GEN MODEL 103 LEAD Back to Search Results
Model Number 302-20
Device Problem Fracture
Event Date 01/30/2017
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported (b)(6) 2017 that a vns patient was scheduled for a prophylactic replacement. High lead impedance was observed prior to the case. The new generator was connected to the lead and diagnostics were repeated. High lead impedance was still observed. The patient had a full revision, with the placement of the new lead and generator on the right side. A portion of the lead was explanted. It was noted by the patient's neurologist that high lead impedance was also observed in clinic after the patient reported some falls. The explant facility does not return the devices without a patient release per policy. Additional relevant information has not been received to-date.

 
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Brand NamePULSE GEN MODEL 103
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 Key6356440
Report Number1644487-2017-03257
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 02/24/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/24/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2005
Device MODEL Number302-20
Device LOT Number009206
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/30/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/23/2003
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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