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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 08/01/2013
Event Type  Malfunction  
Event Description

Additional information was received stating that the vns patient underwent lead replacement surgery on (b)(6 2014. The patient¿s device had been programmed off after high impedance was first observed. X-rays were taken and confirmed a lead break was present prior to replacement. The lead break is believed to have been caused by a car seat belt but no definitive conclusions can be made. The explanted lead was returned to the manufacturer where analysis is currently underway.

 
Manufacturer Narrative

Explant date; corrected data: additional information indicates that the suspect device was explanted on (b)(6) 2014.

 
Event Description

An implant card was received indicating that the vns patient underwent lead replacement surgery on (b)(6) 2013 due to lead discontinuity and malfunction.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. 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

Additional information was received that product analysis was completed on the lead. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the (+) connector ring and (-) connector pin quadfilar coils appeared to be broken approximately 13mm from the electrode bifurcation. Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 13mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the (-) connector pin quadfilar coil break (found at 13mm) and identified the area as being thin, having extensive pitting which prevented identification of the coil fracture type, evidence of electro-etching with residual material. The area was identified as being mechanically damaged which prevented identification of the coil fracture type and residual material. 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 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 except for the setscrew marks observed near the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. Since the original generator was not available the connector pin was inserted into the cavity of generator 102-63434 to verify a dimensional issue in the connector portion of the lead wasn锠preventing the connector pin from being fully inserted into a generator. No obstructions were noted. The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. Canted spring marks were not observed on the rear end of the small o-ring. Continuity checks of the returned lead portion 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 discontinuities in the returned portion of the device which may have contributed to the stated allegations of high impedance. 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 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 Key3833725
Report Number1644487-2014-01370
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/01/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/27/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2016
Device MODEL Number302-20
Device LOT Number3297
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/11/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/06/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/02/2012
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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