• 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 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 102 GENERATOR Back to Search Results
Model Number 102
Event Date 03/22/2012
Event Type  Injury  
Event Description

Clinical received into (b)(6) on (b)(6) 2012 from cm (b)(6) regarding patient (b)(6)'s upcoming replacement. It was reported through clinic notes received on (b)(4) 2012 that the patient felt his seizures had changed. It was reported that he had three seizures which were 'somewhat different'. He reported that with these seizures, he began shaking and then stiffened, the patient also reported eye jerks. It was indicated by the physician that the patient needed his vns battery checked. There were no diagnostic results or patient settings provided in the clinic notes. The patient has since been referred for revision; however, this has not occurred to date. Attempts for additional information have been unsuccessful to date.

 
Event Description

The explanted generator will likely not be returned as per the or coordinator at the hospital, they currently do not have the device to return and they assume that it was discarded in surgery. Attempts for additional information have remained unsuccessful. A rough estimate of battery life was performed with programming history that was only available from the date of implant until (b)(6) 2010. This estimation indicated that the generator may have been at or nearing end of service at the time of replacement.

 
Event Description

Additional information was received on (b)(4) 2012, indicating that the patient underwent revision on (b)(6) 2012. Attempts for product return and additional information have been unsuccessful to date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 102
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 Key2579096
Report Number1644487-2012-01246
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/19/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/17/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2007
Device MODEL Number102
Device LOT Number012830
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/01/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/16/2005
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: 05/17/2012 Patient Sequence Number: 1
-
-