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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 Fracture; Device Displays Incorrect Message ; Lead
Event Date 07/23/2015
Event Type  Malfunction  
Event Description

It was reported that the patient presented to the er with increased seizures below pre-vns baseline. Upon diagnostics while in the er, low impedance was noted. It was stated that the low impedance message appeared indicating the impedance value was less than 600 ohms. The device was thus disabled. Review of the manufacturer's available programming history for this patient revealed that diagnostics on date of implant, (b)(6) 2011, revealed normal impedance values. It was reported that the patient had a status epilepticus event one night while the device was disabled, prior to the date of surgery. The patient underwent generator and lead replacement surgery on (b)(6) 2015 due to prophylactic generator replacement and low impedance. Diagnostics prior to surgery again revealed low impedance. It was also reported that a lead fracture was visually observed during the surgery. The explanted generator and lead have not be received by the manufacturer for analysis to date.

 
Event Description

The explanted generator and lead have been received by the manufacturer for analysis. However, analysis has not been completed to date.

 
Event Description

Analysis of the explanted generator and lead was completed. Analysis of the lead confirmed openings of both the outer and inner silicon tubing in adjacent areas, exposing conductive quadfilar coils and creating a potential short-circuit condition. Analysis of the generator revealed no anomalies. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. The downloaded data from the generator revealed that low impedance was observed (change from 207 ohms to 379 ohms on (b)(6) 2015).

 
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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 Key5009042
Report Number1644487-2015-05500
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Followup,Followup
Report Date 07/23/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/17/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2014
Device MODEL Number304-20
Device LOT Number2786
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/17/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/16/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2010
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: 08/17/2015 Patient Sequence Number: 1
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