• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106 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 - HOUSTON PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Event Date 02/17/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that it was known prior to implant surgery that the patient had severe cardiac issues before implant, but the patient was still implanted due to the vns benefits outweighing the risks. However, the physicians had a suspicion that the patient may have some issues after the surgery. When the case manager called the patient's girlfriend on (b)(6) 2016 to follow-up on the appointment, it was reported that the patient was still in the hospital due to clotting issues. The patient was hospitalized three days before the implant due to heparin bridging. The day after implant on (b)(6) 2016, the patient had surgery to drain the generator incision site. The neck site was also swollen and was noted that it would probably need draining also. She stated that it is not infection. It was indicated that this is not due to the vns, but because of the clotting issues that patient has due to the heparin bridging. The patient was seen on (b)(6) 2016, and the device was turned on. The patient tolerated activation well. The clotting issues had appeared to resolve, and the patient appeared to be fine. It was clarified that the fluid was in the neck, and was since absorbing after the procedure. The physician thought that the clotting was blood. No additional relevant information has been received to date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 106
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key5505080
Report Number1644487-2016-00571
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation OTHER CAREGIVERS
Report Date 02/23/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/16/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/27/2017
Device MODEL Number106
Device LOT Number4614
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/23/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/12/2015
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: 03/16/2016 Patient Sequence Number: 1
-
-