• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 300

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CYBERONICS INC LEAD MODEL 300 Back to Search Results
Model Number 300-20
Event Date 01/01/2013
Event Type  Malfunction  
Event Description

It was reported that during lead replacement surgery device diagnostic testing resulted in high impedance (>= 10,000 ohms) prior to removing the generator from the lead. The generator was disconnected from the lead and generator diagnostics were within normal limits. The surgeon then replaced the lead and generator. A new system was implanted. The generator and lead were returned to manufacturer for analysis on (b)(4) 2013. The lead analysis was completed on (b)(4) 2013. During the visual analysis of the returned 203 mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 2 mm from the end of the connector bifurcation. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. 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, slice mark and cut out hole found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. 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 pins 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 discontinuities in the returned portions of the device which may have contributed to the stated allegations of explanted due to lead break/high impedance. The generator analysis was completed on (b)(4) 2013. Visual examination performed at the bench revealed scratches on the generator can and header most likely associated with manipulation of the device during the explant procedure. Burn marks were also observed on the pulse generator can and header indicating that the pulse generator may have been exposed to an electro-cautery tool. No other surface abnormalities were noted on this device. The generator is operating within specification. The generator was returned due no malfunction suspected/identified. Results of diagnostic testing indicated that the battery status indicated ifi=no in the pa lab. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

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

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEAD MODEL 300
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
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 Key3414519
Report Number1644487-2013-03217
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/18/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/16/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2000
Device MODEL Number300-20
Device LOT NumberA7172
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/25/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/18/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/31/1998
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-