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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 08/03/2011
Event Type  Injury  
Event Description

On (b)(6), 2011 additional information was received when it was discovered that the patient's generator had been replaced on (b)(6), 2011 for prophylactic reasons. The lead impedance was ok after surgery. Good faith attempts were made for the return of the explanted generator but the hospital discarded it. If additional information is received it will be reported.

 
Event Description

On (b)(6) 2011, a pacemaker company's representative reported that the vns patient was going to implanted with a pacemaker because the patient has an arrhythmia. The representative did not know the relationship of the arrhythmia to vns. Clinic notes dated (b)(6) 2011 were received from the vns treating physician. The clinic notes revealed that the vns patient was being referred for prophylactic battery replacement. The patient's settings were output=1. 75ma/frequency=20hz/pulse width=130usec/on time=30sec/off time=3min/magnet output=2ma/magnet pulse width=250usec/magnet on time=60sec. The physician reported that four months ago, while she was in a pain clinic, the patient was found to have bradycardia. Since then, the patient has had multiple presyncopal and syncopal episodes characterized by diaphoresia, light headed and sometimes brief loss of consciousness. The patient was noted to have a prior medical history of mild sleep apnea. The patient is scheduled to have a pacemaker implanted the next week. On (b)(6) 2011, the manufacturer's consultant reported that the vns patient was having their vns battery replaced as well as having a pacemaker implanted that day. The reason for the pacemaker was the patient had a sic sinus syndrome. The battery was programmed to output =1. 75ma/signal frequency=20hz/pulse width=130usec/on time=30sec/off time=3min/magnet output=2ma/magnet on time=60sec/magnet pulse width=250usec. The patient's pacemaker was placed on the right side of the chest and was greater than 8 inches away from the vns generator. Good faith attempts for additional information from the patient's physician regarding the sleep apnea and arrhythmia have been to no avail thus far. Attempts for the return of the explanted generator will be made. When additional information is received, it will be reported.

 
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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 grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2224215
Report Number1644487-2011-02000
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/03/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/26/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2004
Device MODEL Number102
Device LOT Number7570
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received08/30/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/26/2002
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: 08/26/2011 Patient Sequence Number: 1
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