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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 12/12/2012
Event Type  Death  
Event Description

Analysis of the pulse generator revealed that the generator showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The data in the diagaccumconsumed memory locations revealed that 37. 421% of the battery had been consumed. The battery does not suggest an ifi condition. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Event Description

Reporter indicated that the patient passed away in his home on (b)(6) 2012 while on hospice care. It was reported that the patient was expected to pass away. Further follow-up revealed that the cause of death was listed on the death certificate as metastatic colon cancer. Anemia was listed on the death certificate as other significant conditions contributing to death but not resulting in the underlying cause given. No autopsy was performed. Attempts to obtain additional information have been unsuccessful to date. The explanted generator was returned to device manufacturer on (b)(4) 2012 for product analysis. Product analysis is still underway and has not yet been completed.

 
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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 Key2895299
Report Number1644487-2013-00030
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/12/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/03/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2011
Device MODEL Number103
Device LOT Number2577
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/20/2012
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received01/22/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/15/2010
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: 01/03/2013 Patient Sequence Number: 1
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