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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 04/10/2013
Event Type  Injury  
Event Description

Clinic notes dated (b)(6) 2013 indicated that this vns patient had an event that was not typical that involve the same jerking motion but it did not cluster. The patient's seizures typically occur in clusters. During the events, the patient will quickly jerk her arms and legs, typically pulling them in. Sometimes only one arm will pull upward and this can be at slow rhythm or quick, rapid jerks. A cluster of these events will last 7-10 minutes resolving in return to baseline. The second type of event has only occurred twice and involved the same extremity jerking but the patient holding her breath during the jerk. This event occurred three weeks prior to for the first time and lasted 7-10 minutes, like the jerking events. The third type of event involved staring straight forward, possibly slightly upward, while she is non-responsive. This occurred two weeks ago while the patient was hospitalized. The event last 40 seconds and involved arrested behavior including sucking on her pacifier. The device was reportedly at end of service no longer providing a charge. These events had increased over the last few months, likely correlating with battery failure on the vns. The patient was referred for generator revision. Attempts for additional information have been unsuccessful. Surgery is likely but has not taken place.

 
Event Description

On (b)(4) 2013 it was reported that the patient underwent a generator replacement on (b)(6) 2013 due to end of service. The explanted generator was returned for product analysis on (b)(6) 2013. Product analysis on the generator was completed on (b)(6) 2013. Review of the data indicated that the pulse-disabled byte was set to a value that represents a vbat

 
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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 Key3118624
Report Number1644487-2013-01411
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/18/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/17/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2012
Device MODEL Number103
Device LOT Number2641
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/12/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/07/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/19/2010
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: 05/17/2013 Patient Sequence Number: 1
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