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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 05/12/2014
Event Type  Malfunction  
Event Description

Per internal data obtained through product analysis from the explanted generator revealed that there was a change in impedance reading from 2209 ohms to 10000 ohms on approximately (b)(6) 2014.

 
Event Description

It was initially reported that the patient had high impedance. The patient had their generator turned off and was schedule for surgery. The patient had a generator and lead replacement and the explanted products were returned to the manufacturer for evaluation. Product analysis is planned, but has not been completed.

 
Manufacturer Narrative

 
Manufacturer Narrative

Date of event, corrected data: the supplemental report #1 inadvertently did not report this data. Describe event or problem, corrected data: the supplemental report #1 inadvertently did not report this data.

 
Manufacturer Narrative

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

 
Event Description

Additional information was received that product analysis was completed on the generator and lead. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 941 volts as measured shows an ifi=no condition. The data in the diagaccumconsumed memory locations revealed that 57. 124% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Note that a portion of the (-) green electrode quadfilar coil was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 455mm portion the end of the (-) connector pin quadfilar coil appeared to be broken at the distal 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 with pitting. 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. The abraded opening and slice mark found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. 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. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegation of 'fracture of 'high impedance' note that since a portion of the (-) green electrode quadfilar coil 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 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 Key4201473
Report Number1644487-2014-02830
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/30/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/27/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2011
Device MODEL Number302-20
Device LOT Number200991
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/15/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/12/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/29/2008
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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