• 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 09/24/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the patient presented to the er with wound healing issues following recent generator replacement surgery. The patient was evaluated by the surgeon and it was noted that the corner of the generator was exposed. The wound dressings were changed and the patient was prophylactically prescribed antibiotics. The patient was referred for would flap surgery. At a follow-up appointment on (b)(6) 2016, it was noted that the would was healing and was about the size of a dime. Additionally, the generator was no longer exposed. The patient was once gain prophylactically prescribed antibiotics and given additional wound supplies to continue dressing the wound. A few weeks later, the patient's care home reported that the patient had been "horsing around with a friend" which caused the wound to open again and the generator was exposed. When the patient was evaluated by the surgeon on (b)(6) 2016, the generator and lead were out of the pocket. It was noted that the lead was broken. The surgeon then explanted the lead and generator in the office and the explanted products were given to the patient's caregivers. The wound flap surgery was then canceled. A review of manufacturing records showed that the generator was sterilized prior to distribution.

 
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 Key6117942
Report Number1644487-2016-02696
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 10/28/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/21/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/15/2018
Device MODEL Number106
Device LOT Number203698
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/28/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/10/2016
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: 11/21/2016 Patient Sequence Number: 1
-
-