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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 11/12/2012
Event Type  Injury  
Event Description

On (b)(6) 2012 it was reported that the vns patient had 10-12 seizures that morning, approximately 10 head drops with loss of all muscle control which was something new, one focal seizure lasting 3-4 minutes where the patient collapsed in the bathroom, and one grand mal lasting 6 minutes. The patient called 911 and had swiped the vns magnet about 10 times which stopped the focal seizure but not the grand mal seizures. The patient was also given 7. 5mg diastat as he did not have a 10mg portion at the house. The patient was noted to have been ill the last 2-3 weeks with the flu and then had vomiting, but the patient stated that the last time he was sick was on (b)(6) 2012 and he has not had any missed medications. The patient was now also having bradycardia. The physician's office later reported that since the patient was given diastat due to his increase in seizures, this caused the bradycardia. Diastat caused the heart rate to drop; the bradycardia was a side effect of diastat and not related to vns. Attempts for further information from the physician are underway but no additional information has been received to date.

 
Event Description

Additional information was received on (b)(6) 2013 when the manufacturer's consultant stated that the only information that the physician¿s office was able to provide was that the incident was on (b)(6) 2012 and the patient was given ativan and diastat which is what caused the bradycardia. The bradycardia didn't have anything to vns; it was due to the patient's medication - diastat and ativan. The patient's settings were noted to be output=1ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=1. 5ma/magnet on time=60sec/magnet pulse width=250usec and then the patient came back in on (b)(6) 2012 and they increased the output current to 1. 25ma and magnet output to 1. 5ma, the rest of the settings stayed same. The office again reiterated that the event did not have anything to do with vns. No further information was provided.

 
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Brand NamePULSE GEN MODEL 103
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 Key2861715
Report Number1644487-2012-03237
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/12/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/07/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2014
Device MODEL Number103
Device LOT Number3245
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/11/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/18/2012
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: 12/07/2012 Patient Sequence Number: 1
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