• 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 104 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 104 GENERATOR Back to Search Results
Model Number 104
Event Date 01/04/2013
Event Type  Injury  
Event Description

It was reported that the patient had an explant surgery on (b)(6) 2013 where the vns generator and the lead were explanted and the patient was not re-implanted with a new product. The explanted products were returned to the manufacture on (b)(6) 2013 for product analysis which is underway.

 
Event Description

Product analysis was performed and completed for the returned products. Results of diagnostic testing for the vns generator indicated the device was operating properly and communicated properly. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Other than the typical wear and explant related observations, no anomalies were identified in the returned lead portion.

 
Event Description

It was reported that the patient was taken into surgery because her vns generator site wound in the chest was wide open and was not healing. The patient had recently had vns generator replacement surgery performed on (b)(6) 2013. Communication with the physician revealed that he does not believe any patient manipulation or trauma might have caused or contributed to the event, and there were no medical changes. It was also revealed that the patient's wound would not heal and after an office visit on (b)(6) 2013 the surgeon would have noted a hematoma occurring for the third time since the generator replacement surgery on (b)(6) 2013. It was confirmed by the physician that they have tested for infection and no infection was found. It was stated that the patient would have the vns generator and lead explanted on (b)(6) 2013.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing 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 104
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 herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2968019
Report Number1644487-2013-00441
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/21/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/19/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2013
Device MODEL Number104
Device LOT Number202011
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/04/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/28/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/31/2012
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: 02/19/2013 Patient Sequence Number: 1
-
-