• 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 02/23/2016
Event Type  Death  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that a vns patient who recently had a generator replacement was scheduled to have their generator programmed on, but had a slight gap in the incision site. Tape was placed over the site and the patient was rescheduled to have it turned on at a later date. On the day that the patient was scheduled to visit the physician to have the device turned on, he was found dead in his bed. Follow-up by the company representative revealed that it was the neck incision that had opened and there was no presence of infection. The cause of death is unknown to-date. Additional relevant information has not 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 Key5522718
Report Number1644487-2016-00630
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 02/25/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/24/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/06/2017
Device MODEL Number106
Device LOT Number203631
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/25/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/30/2015
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: 03/24/2016 Patient Sequence Number: 1
-
-