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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 06/26/2012
Event Type  Malfunction  
Event Description

An implant card was received on (b)(4) /2012. Diagnostics following the replacement were within normal limits. The explanted products were returned to the manufacturer on (b)(4) 2012. Analysis is not yet complete.

 
Event Description

An article titled "twiddler syndrome with a twist: a cause of vagal nerve stimulator lead fracture" was received by the manufacturer which referenced a case report of a vns patient. ¿approximately 3 months after placement of the vagal nerve stimulator, the family noted subcutaneous protrusion of the device leads deep to the skin below the clavicle. Device function did not appear to be compromised and there was no change in the child¿s seizure frequency. A chest radiograph was obtained at that time and the vagal nerve stimulator leads were noted to be intact. Use of a compressive sling and snug-fitting clothing were advocated at that time. At 7 months after initial placement, the child¿s mother noted the onset of a new type of seizure. Interrogation of the vagal nerve stimulator revealed high impedance and chest radiograph showed twisting of the vagal nerve stimulator wires in the chest wall with fracture of the leads in the low neck. " x-rays were performed, and per the article, they showed there was longitudinal twisting of the vagal nerve stimulator leads in the chest wall and redundant portions of the wires are tightly looped/knotted in the chest wall just above the pulse generator. The device was deactivated and replaced one month later.

 
Event Description

It was reported that the patient's lead was fractured, confirmed through an x-ray. Additional information was received indicating that high impedance, greater than 10,000 ohms was observed during a follow up visit on (b)(6) 2012. At that time, the patient was referred for x-rays which showed a lead fracture. There was no manipulation or trauma to the device, and the x-rays will not be sent to the manufacturer for review. The lead was replaced on (b)(6) 2012. The explanted product has not been returned to the manufacturer to date.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a death or serious injury.

 
Event Description

Analysis on the returned products has been completed. Analysis on the generator was completed on (b)(6) 2012. The results of bench diagnostic testing indicated the device was operating properly. 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. Analysis on the lead was completed on (b)(6) 2012. During the visual analysis the end of the connector pin quadfilar coil appeared to be broken. Scanning electron microscopy was performed on the connector pin quadfilar coil break and identified the area on one of the coil strands as having evidence of a stress induced fracture with mechanical damage and no pitting. Determination could not conclusively be made on the fracture mechanism. The remaining coil strands were identified as having evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. Secondary break lines and pitting were observed on the coil surface. Scanning electron microscopy was performed on a second connector ring quadfilar coil break and identified the area as having extensive pitting which prevented identification of the coil fracture type. The abraded openings and incision mark found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. Abraded openings were also identified in the inner tubing. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

 
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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 Key2669473
Report Number1644487-2012-01889
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/26/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/25/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2015
Device MODEL Number304-20
Device LOT Number201714
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/09/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/03/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/24/2011
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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