• 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 05/01/2012
Event Type  Injury  
Event Description

Clinic notes dated (b)(6) 2012 were received by the manufacturer and reported that the patient had been experiencing lue/lee twitching episodes for the prior six months that last for about three to four minutes with no impairment of consciousness. In the notes dated (b)(6) 2012, it was indicated that the patient usually had mix types of seizure including grand mal, petit mal, partial seizure. After vns placement, he has not had any grand mal seizure in the past five years. Currently, he describes the seizure as arm, eye twitch (early sign). These events were now happening about once a week. Follow-up with the treating physician was performed. He reported that the patient's new seizure type is not believed to be related to any vns problem, and his vns seems to be fully functional. However, the manufacturer battery life calculation determined that as of november he had less than half a year left on his battery. That fact, combined with the fact that since then i have increased his settings to 2. 0ma on (b)(6) 2012, which will most likely lead to an even shorter battery life, led the physician to believe that it is best to replace the generator prophylactically. The physician also reported that he has no way to know if the increased seizures are related to vns. The patient feels the vns stimulation, and the interrogation says that it is not near end of service. Therefore, the physician stated that he has no reason to suspect that the vns is not functioning properly, although perhaps the battery is "just low enough to cause an increase in seizures. " although surgery is likely, it has not occurred to date.

 
Event Description

Attempts for product return were unsuccessful as the explanting facility indicated that they could not locate the explanted generator, so it was assumed by the facility that the device was discarded.

 
Event Description

It was reported by the surgeon's office that the patient had generator replacement surgery on (b)(6) 2012. However, attempts for product return have been unsuccessful to date.

 
Manufacturer Narrative

 
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 Key2874197
Report Number1644487-2012-03354
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/26/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/14/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/21/2008
Device MODEL Number102
Device LOT Number015709
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/17/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/22/2006
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: 12/14/2012 Patient Sequence Number: 1
-
-