• 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 102

  • 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 102 Back to Search Results
Model Number 102
Event Date 08/10/2011
Event Type  Injury  
Event Description

It was reported by a physician that a vns pt experienced her implant becoming more prominent over the lateral chest wall under the arm pit for the pat months. The pt had some chest trauma that could have had contributed to the event and is wearing supportive clothing for the moment. Additional info was received from a company rep indicating that the pt underwent generator reposition. The generator was re-sited medially and superior to the previous position below the clavicle. Moreover, info from the surgeon revealed that the believed cause for the migration was due to a chronic infection / immune response. Good faith attempts to obtain additional info have been unsuccessful to date.

 
Manufacturer Narrative

Device mfg records were reviewed. Review of the mfg records confirmed sterilization for both the generator and lead prior to distribution.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key2249200
Report Number1644487-2011-02116
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/11/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/08/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2010
Device MODEL Number102
Device LOT Number201048
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/11/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2009
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: 09/08/2011 Patient Sequence Number: 1
-
-