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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 01/12/2015
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that the patient's vns battery is "shutting down". Additional information was received that the patient's battery was seen to be low (about 10%). Also, the patient has started having seizures a few weeks prior to visit on (b)(6) 2015 after previously being seizure free. These new seizures are also of a different type than previously, a "black-out seizure" where the patient does not recall events surrounding the black out and 3-4 hours afterwards. Furthermore, it was reported that when swiping the magnet the patient does not feel the magnet stimulation. No additional relevant information has been obtained to date.

 
Event Description

An implant card was received indicating that the patient underwent prophylactic generator replacement. It was reported that the explanted generator was discarded by the explanting facility.

 
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Brand NamePULSE GEN MODEL 103
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key5339671
Report Number1644487-2016-06874
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Followup
Report Date 12/09/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/01/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2012
Device MODEL Number103
Device LOT Number201567
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/15/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/15/2010
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: 01/01/2016 Patient Sequence Number: 1
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