• 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. PULSE GEN MODEL 102 GENERATOR

  • 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. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 11/23/2009
Event Type  Malfunction  
Event Description

It was reported that the vns patient was experiencing pain at his electrode site. The patient¿s device was disabled and the patient was admitted to the hospital for x-rays and further evaluation. The patient¿s physician stated that the patient¿s pain was related to vns. Follow-up revealed that the patient¿s device was disabled because it showed high impedance (dc dc ¿ 7). The patient reported that his pain had improved and was intermittent. The patient was referred for surgery but no known surgical interventions have occurred to date. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin does not appear to be fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, high lead impedance may be due to incomplete lead pin insertion. Review of the available programming and diagnostic history showed normal diagnostic results on the date of implant.

 
Event Description

Additional information was received stating that the vns patient underwent generator replacement surgery on (b)(6) 2014. The replacement generator was tested with the existing lead and diagnostics showed lead impedance within normal limits (impedance value ¿ 3784 ohms). As result, no lead issue was suspected and the reported high impedance was believed to be due to incomplete lead pin insertion. The explanted generator has not been returned to date.

 
Manufacturer Narrative

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

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
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 Key4095469
Report Number1644487-2014-02358
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/20/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/17/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2011
Device MODEL Number102
Device LOT Number2353
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/16/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/15/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-