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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
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/18/2016
Event Type  Death  
Event Description

It was reported that the patient had passed away, as confirmed through an online obituary. She was found unresponsive by the nursing staff at her care facility after a possible seizure. Cpr was attempted, but the patient had expired. The patient was previously in the hospital the week before her passing for blood clots, and was transferred to a skilled nursing facility after being in the hospital for a few days. The device history records of the lead and generator were reviewed and found that all specifications were met prior to distribution. Based on the limited available information about the patient¿s death, an internal classification has determined that the death may be possible sudep. No additional pertinent information has been received to date.

 
Event Description

The county coroner showed that the patient¿s death was reported to them, but they did not handle the patient¿s case and had no autopsy report on it. Communications with the office of the treating physician showed that the patient¿s family was requesting an autopsy. The office confirmed that no warnings for abnormal impedance were seen in the last office visit. The patient¿s treating rehabilitation center reported that in the days preceding her death, the patient was diagnosed with dilantin toxicity. The patient then had a seizure and was also found to be very hypoxic. Computed tomography angiography (cta) showed many pulmonary embolisms. The patient was started on a lovenox/coumadin bridge, and her dilantin dose was decreased. Once patient was medically stable, she was transferred to the rehabilitation center. The next day, the patient had a witnessed seizure and appeared to be stable following the seizure. Approximately one hour later, the patient was found pulseless in her room. She was rushed to the hospital and had cpr performed without success. The patient was pronounced dead by the hospital emergency department. No additional pertinent information has been received to date.

 
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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 Key6252764
Report Number1644487-2017-03032
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/16/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/15/2017
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2015
Device MODEL Number103
Device LOT Number3765
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/09/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/02/2013
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: 01/15/2017 Patient Sequence Number: 1
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