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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 02/01/2014
Event Type  Malfunction  
Event Description

It was reported that the patient needs a lead replacement because the lead is "malfunctioning". It was reported that the patient went through a metal detector and now the lead is "malfunctioning". Clinic notes dated (b)(6) 2014 note that the patient went through a metal detector on (b)(6) 2014 and after that the patient experienced some vague soreness which intensified into severe pain on (b)(6) 2014. The patient described the pain as burning in the neck/chest area. It was noted that the magnet was placed over the generator with no improvement, but gradually subsided. It was noted that the patient still feels very sore and there was no trauma to the neck and no infectious symptoms. The device output current was decreased and the pulse width increased. The notes indicate that the patient will be referred to surgery. The surgeon reported that the patient experienced a significant amount of scar tissue when the current lead was implanted. The physician reported that x-rays were taken, but will not be sent to manufacturer for review. The pain was reported to be with device stimulation. The patient underwent generator and lead replacement on 02/14/2014. An implant card was received that indicated that the patient underwent generator and lead replacement due to "adverse event - pain in left neck". The generator and lead were returned for analysis. Analysis of the generator was completed on (b)(4) 2014. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead is underway, but has not been completed to date.

 
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

The initial mfr. Report stated "the surgeon reported that the patient experienced a significant amount of scar tissue when the current lead was implanted. " this sentence is being corrected to "the surgeon reported that in the lead revision in 2011 that there was a significant amount of scar tissue but was able to remove the electrodes from the nerve and replace with the new (current) lead. " device failure occurred, but did not cause or contribute to a death or serious injury.

 
Event Description

Analysis of the lead was completed on 03/17/2014. Note that a portion of the lead assembly including the (-) green electrode was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 43mm portion quadfilar coil 1 appeared to be broken at the proximal end of the anchor tether. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type, fine pitting and evidence of a stress induced fracture (torsional appearance) on two of the broken coil strands, which most likely completed the fracture. Pitting was observed on the coil surface. 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. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. 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 portions were performed, during the visual analysis, and no other discontinuities were identified.

 
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Brand NameLEAD MODEL 302
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 Key3666903
Report Number1644487-2014-00629
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/06/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/07/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2013
Device MODEL Number302-20
Device LOT Number2394
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/18/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/17/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/02/2009
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: 03/07/2014 Patient Sequence Number: 1
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