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Model Number ASKU
Event Date 10/12/2011
Event Type  Malfunction  
Event Description

The explanted lead and generator have been returned to the manufacturer and device evaluation of the explanted generator has been completed. The generator performed according to functional specifications and there was no abnormal performance or any other type of adverse conditions found. Product analysis of the explanted lead has not been completed at this time.

Event Description

Product analysis of the explanted lead was completed on (b)(6) 2012. During the visual analysis of the returned 151 mm portion the ends of the marked and unmarked quadfilar coils appeared to be broken. Scanning electron microscopy was performed and identified the area on both quadfilar coils as being mechanically damaged which prevented identification of the coil fracture type with pitting on the marked quadfilar coil break area. 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. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids / tissue and white deposits found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. With the exception of the observed discontinuities, 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 unmarked 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. Note that since the marked connector boot, and a large portion of the lead assembly (body) including the electrodes was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

Manufacturer Narrative

Describe event or problem, corrected data - previous report stated that the lead was discarded however it was not. The information has been corrected on this report. Conclusions, corrected data - previous report stated that the lead was discarded however it was not. The information has been corrected on this report.

Manufacturer Narrative

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

Event Description

It was reported that during a prophylactic generator revision surgery, a lead break was identified and the surgery was cancelled as the patient would need a full revision. Follow up with the site revealed that x-rays were not taken prior to surgery and at the time of surgery, a dcdc of 7 was obtained (unknown which mode). No device diagnostics were performed prior to surgery per the physician however the patient was not reporting any issues to the physician which would indicate there was an issue with the lead. Revision surgery to address the high lead impedance will likely occur but has not to date.

Manufacturer Narrative

Event Description

Additional information received revealed that the patient underwent full revision surgery in which the lead and generator were explanted and replaced. The explanted lead was discarded and will not be returned for analysis. Good faith attempts to obtain the explanted generator are in process.

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Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key2323681
Report Number1644487-2011-02648
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/12/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/03/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberASKU
Device LOT NumberASKU
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/22/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/10/2012
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial