BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4853535 · Received June 18, 2015

    Report

    Report Number
    3004209178-2015-11814
    Event Type
    Injury
    Date Received
    June 18, 2015
    Report Date
    May 28, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: 2014-(B)(6), PRODUCT TYPE: EXTENSION. PRODUCT ID: 3550-29, LOT# N153073, IMPLANTED: 2008-(B)(6), EXPLANTED: 2015-(B)(6), PRODUCT TYPE: ACCESSORY. PRODUCT ID: NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) (SN (B)(4)) FOUND THAT THE BATTERY HAD REDUCED CAPACITY DUE TO OVER-DISCHARGE. THE INS WAS RECEIVED WITH NO TELEMETRY AND NO OUTPUT FROM ANY ELECTRODE PAIR. TELEMETRY WAS RESTORED AFTER A FULL PHYSICIAN MODE RECHARGE. AFTER TELEMETRY WAS RESTORED AND A FULL NORMAL RECHARGE, THE INS PASSED FUNCTIONAL TESTING. ACCORDING TO THE TRACE REPORT TAKEN FROM THE INS, THE LAST RECHARGE WHILE IMPLANTED TOOK PLACE ON (B)(6)-2015 AND THE BATTERY WAS CHARGED TO 4.000 VOLTS. ON (B)(6)-2015 THE BATTERY HAD DEPLETED TO THE "LOCK" MODE (LESS THAN 3.575 VOLTS). SUBSEQUENTLY, THE BATTERY DEPLETED TO AN OVER DISCHARGED STATE PRIOR TO BEING RECEIVED FOR ANALYSIS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INCREASE OF DRAINAGE FROM THE GENERATOR WOUND POCKET INCISION. THEREFORE, A NEW POCKET WAS MADE FOR A NEW GENERATOR. THE DEVICE WAS REPLACED WITH A MANUFACTURER¿S PRODUCT. THERE WAS NO PATIENT DEATH AND NO PATIENT INJURY. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396935 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention