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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103

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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 07/15/2011
Event Type  Injury  
Event Description

It was initially reported that the patient's generator was showing that it was near end of life. Later, the patient's mother stated the patient had experienced an increase in seizures, and now how voice changes with stimulation were not as intense, indicating the battery may be failing. The patient was sent for replacement surgery, where the near end of service indicator was seen; the battery was still supplying output current at this time. The patient's last known diagnostics showed the device to be properly functioning. Attempts for further information have been unsuccessful to date.

 
Event Description

Additional information was received on december 8, 2011 when the physician reported that the relationship of the increase in seizures to vns is unclear. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the increase in seizures. The patient's settings prior to battery replacement were listed as output=3. 25ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=1. 8min/magnet output=3. 5ma/magnet on time=60sec/magnet pulse width=500usec/eri=yes on (b)(6) 2011. The physician also provided clinic notes dated (b)(6) 2011 that state the patient was doing well in terms of seizures and that his last seizures as about a year ago. After battery replacement, the patient was programmed back up to output=3. 25ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=1. 8min/magnet output=3. 5ma/magnet on time=60sec/magnet pulse width=500usec during her follow up visit on (b)(6) 2011.

 
Event Description

Attempts for the return of the patient's explanted generator for product analysis have been made, but the explanted product has not been received by the manufacturer. The patient's programming history was reviewed and on (b)(6) 2010 the patient's generator showed 5 months left till end of service.

 
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Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058 770
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 Key2257002
Report Number1644487-2011-02157
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial,Followup,Followup
Report Date 08/25/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/16/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2011
Device MODEL Number103
Device LOT Number201043
Was Device Available For Evaluation? No
Date Manufacturer Received12/08/2011
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: 09/16/2011 Patient Sequence Number: 1
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