• 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 103
Event Date 04/27/2010
Event Type  Injury  
Event Description

A patient reported that during implant surgery, the surgeon implanted the vns generator on the right side of the patient's chest as the patient was implanted with a pacemaker on the left side. During implant, the patient experienced asystole and had to be resuscitated. During surgery, the patient also experienced a large seizure when the vns was programmed on and now the patient is having more seizures than she did prior to being implanted with the device. The patient also stated that the device is pushing up against her skin which causes pain while dressing. Per the patient, the surgeon stated that the generator battery may have been used up during surgery, and he was unsure if the device was still functioning. Follow up with the neurologist revealed that the patient has a history of arrhythmia. The generator is registering magnet swipes. He does not know if the increase in seizures is above baseline levels. The protrusion response was that the device looks no different from any other patient other than it being on the right side. He will do a symptomatic therapy for the pain and possible consultation with a surgeon for a revision of the implant if desired by the patient. He does not know of any trauma or manipulation. Good faith attempts to obtain additional information from the surgeon have been unsuccessful to date.

 
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 Key1851128
Report Number1644487-2010-02206
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 09/02/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/30/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2011
Device MODEL Number103
Device LOT Number2604
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received09/02/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/30/2010 Patient Sequence Number: 1
-
-