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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 01/01/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the patient began experiencing painful stimulation and pain, in their neck and left arm, associated with vns after implantation of a back stimulator. The pain was said to occur every 3 minutes, and resulted in the patient's device being turned off. Device diagnostics were performed prior to the device being turned off, and were found to be within normal limits. After the device was turned off, the patient reported that they were still experiencing both neck and left arm pain due to the vns and felt as if the device was still providing stimulation and the physician stated that although the device was turned off, a device malfunction could not be ruled out. The patient wanted the vns removed, so the patient underwent device replacement surgery. The newly implanted device was turned on and previous symptoms that the patient had reported were not seen. Additional information was received from the physician that the patient started experiencing the pain sometime after her tens unit was placed in her back. The physician also stated that they are not sure what caused the pain however the patient thought it may have been related to the tens unit. The physician went on to state that the patient's surgery referral for the patient's comfort and to ensure that the patient continued to have benefit from the vns. The physician stated that they were not positive of what could be cause the painful stimulation and stated it could be possibly due to the tens unit, abnormality of vns, or related to patient anxiety, and the physician could not sure what could have caused the pain while the device was on. No other 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 Key8071032
Report Number1644487-2018-02037
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/18/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/14/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/18/2015
Device MODEL Number103
Device LOT Number3794
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/01/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/04/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/15/2013
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: 11/14/2018 Patient Sequence Number: 1
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