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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
Event Date 04/16/2014
Event Type  Malfunction  
Event Description

It was reported that device diagnostics resulted in high impedance (6585 ohms). The physician chose to leave the device programmed on because the patient has had great efficacy. X-rays were performed. Attempts to obtain additional relevant information have been unsuccessful to date. No known surgical intervention has been performed to date.

 
Event Description

Review of x-rays by manufactuer was unable to be determined if the connector pin of the lead was fully inserted inside the connector block on the generator. There are no apparent sharp angles or gross fractures of the lead that could be seen in the images given. There was nothing seen that would indicate there was any damage to the generator or lead causing a high impedance condition; however, the presence of a micro-fracture in the lead or incomplete pin insertion cannot be ruled out.

 
Event Description

Clinic notes dated (b)(6) 2015 note that the patient has experienced poor seizure control for the past year. Device diagnostics again resulted in high impedance (>7,000 ohms). The notes indicate that the physician is considering right sided placement of the vns since the patient has previously undergone generator and lead replacement on the left side. It was noted that the patient will undergo vns revision and the new system will be placed on the right side. No known surgical interventions have occurred to date.

 
Event Description

Analysis of the explanted generator was completed. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Event Description

Additional information was received that the patient underwent a generator and lead replacement surgery on (b)(6) 2015 due to prophylactic generator replacement and high impedance. The generator was received by the manufacturer and analysis is currently underway. The lead will not be returning; therefore, no analysis on the lead can be completed. During review of programming and diagnostic history, it was observed that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed low impedance (<=600 ohms).

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer, no gross lead discontinuities visualized.

 
Manufacturer Narrative

Review of the available programming and diagnostic history.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key4277356
Report Number1644487-2014-03129
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/29/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/25/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2015
Device MODEL Number304-20
Device LOT Number3103
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/15/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/12/2011
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: 11/25/2014 Patient Sequence Number: 1
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