• 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 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. PULSE GEN MODEL 103 Back to Search Results
Model Number 104
Device Problems Pin; High impedance; Malposition of device ; Lead
Event Date 10/01/2009
Event Type  Malfunction  
Event Description

Reporter indicated that the patient had recently undergone a generator replacement surgery. At the patient's first visit to the neurologist, it was noted that the device was registering high impedance. X-rays were taken and sent to the manufacturer for analysis, which found that there may have been an issue with proper insertion of one of the lead pins into the generator. The patient was taken into surgery to reseat the lead pin to see if the high impedance resolved. Once the lead pin was removed and reinserted properly, the high impedance resolved. Attempts for information as to whether diagnostics were performed at the original replacement surgery, were unsuccessful, thus the cause for the lead pin not being properly connected to the generator cannot be determined.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE 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 Key1549618
Report Number1644487-2009-02538
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 10/13/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/12/2009
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 Number104
Device LOT Number201114
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received10/13/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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

-
-