• 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 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 INC PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 01/31/2013
Event Type  Injury  
Event Description

On (b)(4) 2013 it was reported that the vns patient¿s vns generator migrated down into her armpit. It was later reported that the migration was noticed shortly after the patient¿s implant, approximately nine months ago. Surgery is planned but has not occurred to date to fix the migration issue. Diagnostics were performed on (b)(6) 2013 and the physician reported that the device seemed to be functioning properly. No patient manipulation or trauma was reported. At this point it is unknown if non-absorbable sutures were used to secure the generator to fascia during implantation. Good faith attempts were performed and it was later reported that the migration of the vns generator was first observed on (b)(6) 2013. No patient manipulation or trauma is believed to have caused the migration. However, it is still unknown at this point if non-absorbable sutures were used to secure the generator to fascia during implantation.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3241521
Report Number1644487-2013-02190
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/27/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/22/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2013
Device MODEL Number103
Device LOT Number201943
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/27/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/09/2011
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: 07/22/2013 Patient Sequence Number: 1
-
-