BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 4609810 · Received March 17, 2015

    Report

    Report Number
    3004209178-2015-04846
    Event Type
    Malfunction
    Date Received
    March 17, 2015
    Report Date
    February 23, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 7752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012-0, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3998, LOT# V855145, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: A01411002, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: RECHARGER. PRODUCT ID: A01411002, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT LOST 50 POUNDS AND THEIR IMPLANTABLE NEUROSTIMULATOR (INS) MOVED AROUND A LOT IN THE POCKET. THE PATIENT WAS HAVING DIFFICULTY WITH RECHARGING SINCE THEN. THIS DIFFICULTY STARTED 6-8 MONTHS PRIOR. THE PATIENT SAW A MANUFACTURER REPRESENTATIVE (REP) (B)(6) 2015 AT THE HEALTHCARE PROVIDER (HCP) OFFICE AND THEY DID AN ANTENNA LOCATE (AL) FEATURE WITH SUCCESS. THE PATIENT WAS TRYING TO DO THE AL FEATURE THE DAY OF THE REPORT AND WAS HAVING ISSUES WITH THE REP OVER THE PHONE. THE PATIENT WAS ABLE TO MAKE A CONNECTION USING THE AL FEATURE WITH 7 OF 8 BOXES. THE PATIENT MENTIONED THAT THE RECHARGER BELT WOULD COME UNDONE. INFORMATION REGARDING IF THE PATIENT STILL HAD CONCERNS WITH THEIR DEVICE OR THERAPY HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182152 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1