• 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 11/04/2011
Event Type  Injury  
Event Description

On (b)(6) 2011, clinic notes were received through case management. Review of the clinic notes dated (b)(6) 2011 revealed that the vns patient was experiencing an increase in seizures. The physician stated on (b)(6) 2011 that over the last 50 days, the patient had 11 seizures, which is somewhat more than last time. The patient's seizure frequency was 0. 22 as compared to 0. 14 of last time reported the physician. The physician stated that the recent increased seizure frequency had probably been due to withdrawal from tapering the carbatrol. The patient's settings are output=3. 5ma/frequency=30hz/pulse width=130usec/on time=21sec/off time=1. 1min/magnet output=3. 5ma/magnet on time=7sec/magnet pulse width=130usec. On (b)(6) 2011, the vns patient reported that she started to have an increase in seizures about a month ago and has been having to swipe the magnet more to get the same effect. The patient's generator was reported to be at end of service and the end of service was stated to be the cause of the recent increase in seizures. The patient was referred for battery replacement but surgery has not yet occurred. A battery life calculation was performed with the programming history available which showed 1. 4 years until eri=yes. However, no diagnostic history was available effects the accuracy of the battery life calculation. Although additional information has been requested from the physician, no further information has been received to date.

 
Manufacturer Narrative

Analysis of programming history.

 
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
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 Key2350959
Report Number1644487-2011-02867
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 11/09/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/29/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date11/30/2009
Device MODEL Number102
Device LOT Number200681
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/09/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/18/2007
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: 11/29/2011 Patient Sequence Number: 1
-
-