• 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. DEMIPULSE GEN MODEL 103

  • 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. DEMIPULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 03/01/2010
Event Type  Malfunction  
Event Description

It was initially reported by the surgeon that the patient is having his battery replaced due to eos. Patient's eri status showed that only one month is remaining. Explanted generator was returned to manufacturer for analysis. Analysis was completed by the manufacturer. Product analysis of the returned generator revealed that an end of service warning message was received and found to be associated with the output being disabled by the pulse generator. Once the output was re-enabled, the reported demipulse eos condition was duplicated during diagnostic testing, using parameters from the programming history, which indicated that the generator was approaching eos, (1 month at the returned parameters). There were no adverse functional, mechanical, or visual issues identified with the returned generator. Additional information received from the surgeon's nurse revealed that electrocautery was used during explant of the generator. She did not know the specifics of the electrocautery. Further investigation determined that the root cause of the eos warning messages as being an asic latch-up condition resulting from the pulse generator receiving an electrical transient during implant surgery. The electrical transient is the result of electromagnetic induction (emi) or electrostatic discharge (esd). This emi and/or esd causing the asic latch-up can be attributed to: the use of monopolar electrosurgery in direct contact with the pulse generator; monopolar electrosurgery in close vicinity to the pulse generator; or a major electrostatic discharge.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEMIPULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1711607
Report Number1644487-2010-01258
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/07/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/26/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2011
Device MODEL Number103
Device LOT Number2370
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer03/25/2010
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/07/2010
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-