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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 High impedance
Event Date 09/23/2019
Event Type  Malfunction  
Event Description

An implant card was received that indicated the patient's generator was replaced prophylactically. The lead impedance with the replacement generator was indicated as high, >=10,000 ohms. Diagnostics prior to the generator replacement are unknown to date. The or support specialist company representative indicated that the surgeon does not historically let representatives in the operating room. A surgical resident indicated that there was high impedance, prior to the surgeon entering the room. The representative suggested troubleshooting, but it is unknown to date if the troubleshooting was performed as the representative was not able to go into the room. At the end of the generator replacement case it was reported that there was still high impedance detected, the resident indicated that they inspected the lead and "noticed kinking and a small cut in the lead tubing. " no known relevant surgical intervention has occurred with the suspect product, the lead, to date. No further relevant information has been 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
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key9191162
Report Number1644487-2019-01999
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 10/15/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/15/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2003
Device MODEL Number300-20
Device LOT Number2702
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/23/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/10/2001
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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