• 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 302

  • 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 302 Back to Search Results
Model Number 302-20
Event Date 09/06/2013
Event Type  Malfunction  
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

On (b)(6) 2013, it was reported that high impedance was observed while the patient was still in the hospital following generator replacement (due to prophylactic reasons). During the surgery on (b)(6) 2013, diagnostics were within normal limits; however, on (b)(6) 2013, the device was showing about 7000 ohms when interrogated. Per the physician, the patient did not have any falls while in the hospital. During a review of the patient's x-rays, it was noted that the patient appears to have the lead on the right-hand side. There were no observed gross fractures noted. The lead pin insertion issue cannot be ruled out as potential cause since the surgeon has a history of quickly going through that step during surgery. Review of the generator and lead device history records confirmed all quality tests were passed prior to distribution. No additional information has been received.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEAD MODEL 302
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 Key3388730
Report Number1644487-2013-03047
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/06/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/04/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2010
Device MODEL Number302-20
Device LOT Number200675
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/06/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/27/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-