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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problems Corroded ; Fracture; Mechanical Problem; Under-Sensing ; Low impedance
Event Date 06/05/2017
Event Type  Malfunction  
Event Description

It was reported that the generator was not detecting heart rate. The internal data of the generator was reviewed and it was determined that low impedance had been detected on the device in the past as well as a large drop in impedance. Low impedance may interfere with heartbeat detection. The generator was later able to detect heart rate when the sensitivity was set to its least sensitive detection setting (sda sensitivity - 1). However, approximately four months later, the generator continued to have difficulty detecting heart rate. Low impedance was detected intermittently through system diagnostics. The patient reported that approximately a year ago she had felt a 'movement' in her neck, where the lead connected to the nerve and when she moved her head back, the movement reversed and 'went back. ' the patient said that she still felt normal and magnet mode stimulation. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

 
Event Description

It was reported that the patient's lead and generator had been replaced due to low impedance. During explant a kink in the lead was observed that had caused the tubing to rupture. Reportedly there was nothing unusual about the placement of the lead on the nerve. The explanted lead and generator were received, but product analysis on the devices have not been completed to date. No further relevant information has been received to date.

 
Manufacturer Narrative

(b)(4).

 
Event Description

Product analysis was completed on the returned generator. The generator was able to sense heart-rate normally. No anomalies were identified with the generator. Product analysis was completed on the returned lead. The lead was received in two pieces and the electrodes were not received. Two (2) abraded openings in just outer tubing were identified. One abraded opening in the inner and outer tubing was observed. At this opening, a lead break in the positive coil was found and pitting conditions were observed at the location. Dried body fluids were identified in the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the cut ends of the returned lead portion. No other anomalies were identified in the returned lead portions. No further relevant information has been received to date.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key7011776
Report Number1644487-2017-04745
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 04/18/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/08/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/29/2019
Device MODEL Number304-20
Device LOT Number203511
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/08/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/02/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/15/2015
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: 11/08/2017 Patient Sequence Number: 1
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