• 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 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 103 GENERATOR Back to Search Results
Model Number 103
Event Date 05/01/2013
Event Type  Injury  
Event Description

On (b)(4) 2013, it was reported by the surgeon that the patient was recently implanted on (b)(6) 2013 and came into the hospital on (b)(6) 2013 with a wound on her neck. It was stated that the patient fell in the shower from a seizure and her neck incisions were ripped open. After the patient went to the hospital, her sutures were removed and the surgeon re-sutured the wound and closed it. No other interventions were taken or planned. Diagnostic results were ok. Follow up with the nurse at the surgeon's office found that the wound was not related to vns. It was stated that the wound was directly caused by the seizure incident which was unrelated to vns. No known medication changes preceded the event. No other information was provided.

 
Manufacturer Narrative

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3137281
Report Number1644487-2013-01631
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/02/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/30/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2014
Device MODEL Number103
Device LOT Number202364
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/02/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/09/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-