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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
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/23/2018
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was stated that a patient may have a wound around her generator site that had opened up and led to infection, due to patient twiddling or manipulation. The patient was scheduled for a full revision surgery. Device history records were reviewed for the patient's devices. Both lead and generator were sterilized and passed all quality inspections prior to distribution. A battery replacement surgery occurred and impedance was ok. No further relevant information has been received to date.

 
Manufacturer Narrative

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

 
Event Description

Follow up with the physician confirmed that both the wound and infection were caused by patient manipulation and scratching of the generator site. It was stated that the wound was first noted on (b)(6) 2018, and that both wound and infection were resolved. No additional relevant information has been received to date.

 
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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 Key7596391
Report Number1644487-2018-01021
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 07/09/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/15/2018
Device MODEL Number106
Device LOT Number5056
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/09/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/20/2016
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: 06/13/2018 Patient Sequence Number: 1
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