BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 6077467 · Received November 3, 2016

    Report

    Report Number
    3004209178-2016-23196
    Event Type
    Injury
    Date Received
    November 3, 2016
    Report Date
    November 3, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377760, LOT# V010420, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 377760, LOT# V011055, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE COVERAGE FROM THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT COVERING THE PAINFUL AREA. THE PATIENT FELL THIS PAST (B)(6) ON THE ICE AND LANDED ON RIGHT THEIR BUTTOCKS AND INS. PER PATIENT, THE INS HAD MIGRATED DOWN THE BUTTOCKS TO AN UNCOMFORTABLE AREA. AN IMPEDANCE CHECK SHOWED ALL CONTACTS INTACT AND FUNCTIONAL. REPROGRAMMING WAS PERFORMED TO COVER THE PAINFUL AREA. THE PATIENT WAS INSTRUCTED TO CONTACT THEIR IMPLANTING NEUROSURGEON ABOUT THE LOCATION OF THE INS. IT WAS NOTED THAT THE ISSUE WASN¿T RESOLVED AT THE TIME OF THE REPORT. THE PATIENT¿S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. ADDITIONAL INFORMATION RECEIVED FROM THE REP REPORTED THAT THE PATIENT WAS SCHEDULED FOR A POCKET REVISION ON (B)(6) 2016 TO REPOSITION THE INS. THE ISSUE OF THE COVERAGE HAD BEEN RESOLVED, BUT THE INS MIGRATION HADN¿T BEEN RESOLVED. THE PATIENT WAS IMPLANTED FOR CHRONIC LOW BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726554 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention