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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103 GENERATOR

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LIVANOVA USA, 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 07/16/2018
Event Type  Injury  
Manufacturer Narrative

Device evaluation is not necessary because the reported event has been determined as not related to the vns generator.

 
Event Description

It was reported by the patient that their generator had migrated into her armpit. The patient was experiencing adverse events related to the generator migration such as pain around her collarbone and ribs. The patient also reported that she had lost a bit of weight. The patient was referred for surgery. No known surgical intervention has occurred to date. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 103
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 Key8095773
Report Number1644487-2018-02135
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 12/21/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/22/2016
Device MODEL Number103
Device LOT Number203064
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/04/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/31/2014
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: 11/21/2018 Patient Sequence Number: 1
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