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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 12/27/2012
Event Type  Malfunction  
Event Description

Analysis of the returned vns generator and lead was completed. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. During the lead visual analysis of the returned 43mm portion what appeared to be rust-like deposits and pitting were observed on the connector pin surface. Scanning electron microscopy was performed and identified evidence of pitting on the surface of the connector pin. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed on the connector pin rust-like deposit and identified the area as consisting of chromium, iron, nickel and molybdenum. Another eds procedure was performed on the clean surface of the connector pin and identified the area as consisting of chromium, iron, fluorine, nickel and molybdenum. A definite cause for the pitting could not be determined based on the lead portion returned. During the visual analysis of the returned 43mm portion the ends of the quadfilar coils appeared to be twisted together inside the connector boot. Scanning electron microscopy was performed and identified the area as being twisted together and mechanically damaged which prevented identification of the coil fracture type with residual material and no pitting. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. These findings are consistent with patient manipulation/rotation of the device while it was implanted (twiddler). The condition of the remaining portions of the returned lead is consistent with that which typically exists 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. However, based on the overall condition of the returned lead, there appears to be evidence of significant manipulation, which may have contributed to the observed stress-induced fractures. Note that since 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.

 
Event Description

Reporter indicated that during a prophylactic vns generator replacement surgery, the lead was noted to be broken when the generator was removed from the patient. It is not known if the lead was accidentally cut in the surgery or broke prior to the surgery. Vns diagnostics testing immediately prior to the surgery revealed normal results. A new lead and generator were implanted. The explanted lead and generator have been returned and are pending analysis. Attempts for additional information are in progress.

 
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. Additionally, the failure was due to significant patient manipulation 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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2928444
Report Number1644487-2013-00205
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/27/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/24/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2008
Device MODEL Number302-20
Device LOT Number200246
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/11/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/05/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/30/2006
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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