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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Event Date 01/26/2016
Event Type  Malfunction  
Manufacturer Narrative

Suspect device udi: (b)(4).

 
Event Description

A provider reported that a patient who had previously received a right-sided vns system had been in the hospital for gastrointestinal bleeding and esophagus erosion testing. It was reported that the gi bleed and esophagus erosion developed after right sided placement. The patient's seizures have increased over the past month as the vns titration process is evolving. It is unknown if any of the reported conditions are due to vns. Diagnostic testing of the device revealed all measured values were within normal limits. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

It was reported by the patient's nurse practitioner that the patient was experiencing vocal cord paralysis, as captured in mfr. Report 1644487-2017-03622, as well as gastrointestinal bleeding. The patient's ent's clinic notes indicated that there was a report of bleeding from ulcers in the patient's esophagus and bowels. The patient's mother later called and wanted to know whether the vns could cause throwing up blood or ulcers in the stomach. The patient's surgeon also wanted to know whether the vns could cause gastrointestinal issues such as ulcers. The patient's device was disabled due to concerns that the patient's gastrointestinal bleeding may be caused by the vns. No further relevant information has been received to date. No known relevant surgical intervention has occurred to date.

 
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Brand NamePULSE GEN MODEL 106
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 Key5597943
Report Number1644487-2016-00863
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Followup
Report Date 04/16/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/22/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/20/2017
Device MODEL Number106
Device LOT Number203437
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/20/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/28/2015
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: 04/22/2016 Patient Sequence Number: 1
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