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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 102

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CYBERONICS INC PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 08/01/2011
Event Type  Injury  
Event Description

Analysis was completed on the returned generator. Upon analysis, no anomalies were noted and the device performed according to specifications.

 
Event Description

It was reported via clinic notes that the pt was having more convulsions--at least 6 in the past 6 weeks. The pt was also having some dizziness with the increase and did not feel the vns stimulation very strong anymore. Per physician, even though eri=no, he feels the generator needs to be prophylactically replaced based on the length of time implanted. Pt underwent prophylactic generator replacement on (b)(6) 2011. Attempts for further info have been unsuccessful to date. Product has been returned to the mfr, but analysis is pending.

 
Event Description

Additional information was received from the physician. Per physician, the increased seizures is related to loss of generator efficacy; and is back to pre-vns baseline levels. Only one type of seizures have increased. No causal or contributory programming changes, medication changes, or other external factors precede the onset of the events. The dizziness the patient was experiencing is not related to vns stimulation and is related to the patient's medications. No patient manipulation or trauma occurred that is believed to have caused or contributed to the events. Per physician, the seizures have somewhat improved since the generator replacement.

 
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Brand NamePULSE GEN MODEL 102
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 Key2267804
Report Number1644487-2011-02256
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/24/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/23/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2006
Device MODEL Number102
Device LOT Number11652
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer09/09/2011
Is The Reporter A Health Professional? No
Date Manufacturer Received11/07/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/02/2004
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: 09/23/2011 Patient Sequence Number: 1
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