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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 02/04/2015
Event Type  Injury  
Event Description

Clinic notes were received indicating that the vns patient was referred for generator replacement surgery due to a depleting battery and an increase in seizures. The patient's device was tested during an office visit on (b)(6) 2015 and diagnostic results showed normal device function and battery status = ok. Since the patient's last office visit on (b)(6) 2015, the patient began having two amnestic events per month along with "zoning out" spells. The patient denied any missed dosages of medications or any illness, and the patient's last lab tests showed medication levels within normal limits. A battery life calculation using the available programming history showed approximately 2 years remaining. No known surgical interventions have occurred to date. No further information relevant to the event has been received to date.

 
Event Description

Follow-up revealed that the physician believed the patient¿s issues would resolve following replacement of the patient¿s generator battery. An implant card was received indicating that the patient underwent generator replacement surgery on (b)(6) 2015. The explanting facility discarded the explanted device; therefore, no analysis can be performed.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4872598
Report Number1644487-2015-05033
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/03/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/26/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2010
Device MODEL Number102
Device LOT Number200961
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/09/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/24/2008
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: 06/26/2015 Patient Sequence Number: 1
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