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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. BIPOL LEAD MODEL 300

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LIVANOVA USA, INC. BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Device Problem Fracture
Event Date 01/01/2018
Event Type  Malfunction  
Event Description

Per nurse practitioner, the patient reported feeling intense stimulation recently to the point of waking him up at night and bouts of severe cough and unable to speak intermittently. System diagnostic with high impedance 6113 ohms was detected. Prior to these recent changes the patient reported not detecting stimulation and no voice strain with 0. 75 milliamps and 1. 0 milliamps magnet activation. The patient also reports no blunt trauma to the area around the generator and/or neck area. Patient does bowl on a regular basis and reports these intense stimulations during sleep, laying down, during bowling, standing and other times in the day as well. No known surgical interventions have occurred to date.

 
Event Description

It was reported that the patient's device was permanently disabled and that the patient's symptoms resolved with the disablement. The patient does not experience a change in seizures with disablement.

 
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Brand NameBIPOL LEAD MODEL 300
Type of DeviceLEAD
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
LIVANOVA USA, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7268872
Report Number1644487-2018-00213
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 08/16/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2001
Device MODEL Number300-20
Device LOT Number27959C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/23/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/31/1999
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/13/2018 Patient Sequence Number: 1
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