• 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 09/01/2011
Event Type  Malfunction  
Event Description

Additional information received revealed that 3-0 vicryl sutures were used to secure the generator to the fascia during implant on (b)(6) 2010.

 
Event Description

Product analysis of the explanted generator has been completed. Results of diagnostic testing indicated that the device was operating properly and communicated properly. Post burn-in electrical test results showed that the pulse generator performed according to functional specifications.

 
Event Description

It was initially reported that the patient that after losing (b)(6) lbs. Intentionally, she feels like her generator has migrated to her armpit. The patient is also having severe headaches on the left side and has been experiencing them for the past (b)(6). The pain in intermittent and feels like it is occurring when the device stimulations. The pain is sharp and does not resolve with medication treatment. The patient was instructed to follow up with her physician. Later information was received indicating that the headaches resolved when the magnet was used to disable the device. The patient is going to be referred to a surgeon for the migration. The pain was quite significant in that the patient had absolutely no relief unless the magnet was secured over the generator site however then the patient ran the risk of not getting the therapy. The reason they believed the device was malfunctioning was because the patient did not have these headaches before and the pain began rather quickly and worsened only to improve when the device was disabled with the magnet. There were no medication changes or other factors preceding the onset of the headaches. There were no reports of trauma either. The generator was replaced and the patient has been doing well since replacement with no further pain. The explanted generator has been returned to the manufacturer and is currently undergoing product analysis.

 
Manufacturer Narrative

 
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 770
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2341941
Report Number1644487-2011-02789
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/27/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/18/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2011
Device MODEL Number103
Device LOT Number2624
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/11/2011
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/12/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/05/2010
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: 11/18/2011 Patient Sequence Number: 1
-
-