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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 06/01/2015
Event Type  Death  
Manufacturer Narrative

 
Event Description

It was reported by the company representative that the patient had passed away. An obituary search provided the date of the patient's death, but no cause of death was provided. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

Clinic notes were received regarding the patient's reason for admission to the hospital and her death. It was noted the patient was admitted to the hospital on (b)(6) 2015 and discharged on (b)(6) 2015. It was noted that the day before she was admitted, she was on the toilet and fell to her side, injured her left ribs, but the staff did not think too much about it because she did not really complain. But, as time went on, she started complaining more of shoulder pain, breast pain, and lateral chest pain, so they brought her into the e. R. Where 2 fractured ribs on the left anterolateral side were found. It was felt by the physician that the patient should be admitted so that they could observe her. The patient was admitted and had no problems over the weekend. On monday morning, the physician was told the patient had an arrest. He discussed with the physician on call and the nurse and it was explained that around 3 am the patient had some nausea and abdominal pain. They provided the patient with zofran and then when they went to check on her again, she had vomited and it was noticed she has some pudding around her mouth. At that time, she was just staring and then just "went out. " a sternal rub was performed and a code was called, but they were unsuccessful. It was decided the patient most likely aspirated and an autopsy was not performed.

 
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Brand NamePULSE GEN MODEL 102
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 Key5463400
Report Number1644487-2016-00424
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/29/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/26/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2009
Device MODEL Number102
Device LOT Number200611
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/07/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/10/2007
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: 02/26/2016 Patient Sequence Number: 1
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