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U.S. Department of Health and Human Services

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

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LIVANOVA USA, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Event Date 07/15/2016
Event Type  Injury  
Manufacturer Narrative

Suspect device udi: (b)(4).

 
Event Description

It was reported by a vns patient's implanting physician that the patient's incision on his back had opened. It was noted that only the skin had opened and the generator looked covered. The physician said the intact skin was reinforced with steristrips. The local care for the wound would be provided by patient's parents. Additional relevant information has not been received to-date.

 
Event Description

Follow-up from the surgeon 10/14/2016 provided that the patient's incision opened right after the surgery due to the patient picking at it. The wound opening was superficial only and healed up after local care.

 
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Brand NamePULSE GEN MODEL 106
Type of DeviceGENERATOR
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
LIVANOVA USA, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key5870030
Report Number1644487-2016-01805
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup
Report Date 12/07/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/11/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2017
Device MODEL Number106
Device LOT Number203814
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/13/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/07/2016
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: 08/11/2016 Patient Sequence Number: 1
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