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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Event Date 03/31/2004
Event Type  Injury  
Event Description

Initially, it was reported that the patient's family did not think vns therapy was working for the patient. The physician reported that lack of efficacy was never observed and feels that efficacy was present. Clinic notes dated (b)(6) 2013 note that the patient's family thinks the patient's seizures became worse with vns. The vns was programmed off and the seizure frequency has not improved. Attempts to obtain information as to whether or not the seizures increased with vns have been unsuccessful to date.

 
Event Description

Additional information was received that the patient had a generator replacement. The generator will not be returned to the manufacturer as the hospital does not return explanted products to the manufacturer.

 
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Brand NamePULSE GEN MODEL 102R
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 Key3907073
Report Number1644487-2014-01649
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/03/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/01/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2005
Device MODEL Number102R
Device LOT Number010220
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/15/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/17/2004
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: 07/01/2014 Patient Sequence Number: 1
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