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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/27/2018
Event Type  Injury  
Manufacturer Narrative

Device evaluation is not necessary because the reported event has been determined as not related to vns therapy but related to the implanting procedure.

 
Event Description

It was reported that a patient's device was explanted due to infection. The patient had had a recent battery replacement surgery which had opened up. It was stated that the mom did not get an antibiotic order filled, so the wound led to infection and the device was visible. Device history records were reviewed for the implanted devices. Both the lead and generator were sterilized and passed all quality inspections prior to distribution. No additional information has been received to date.

 
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Brand NamePULSE GEN MODEL 106
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7750790
Report Number1644487-2018-01334
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/05/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number106
Device LOT Number204477
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/11/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/14/2018
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: 08/06/2018 Patient Sequence Number: 1
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