Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
-

MAUDE Adverse Event Report

Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA
 

CYBERONICS, INC. PULSE GEN MODEL 103   Back to Search Results
Model Number 103
Event Date 05/01/2008
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

It was reported to manufacturer that shortly after generator replacement surgery, the vns pt opened the chest incision and pulled out the device. Further follow up with the treating physician revealed that the bulky dressing and the "glue" that was used to close the incision following surgery likely bothered the pt. As a result, the pt picked at the site, eventually opening the wound and pulling out the device. The pt has profound mental retardation. Additional info received from the nursing staff at the group home where the pt is cared for, indicated that the pt had picked at the generator incision site after surgery due to irritation from bulky dressing and ended up pulling out the lead. The surgeon then explanted the generator at a later date. At this time, the pt is being evaluated to see if a re-implant will be performed.

 
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
michael carroll
100 cyberonics blvd., ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key1047924
MDR Report Key1080753
Event Key1038671
Report Number1644487-2008-01674
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/27/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/23/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date02/28/2010
Device MODEL Number103
Device LOT Number200774
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received06/27/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

 
-
-
-
-
-