BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3062677 · Received April 17, 2013

    Report

    Report Number
    3004209178-2013-06413
    Event Type
    Injury
    Date Received
    April 17, 2013
    Report Date
    April 12, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3487A-33, LOT# V041664, IMPLANTED:(B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3487A-33, LOT# V041664, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-33, LOT# V041664, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-33, LOT# V041664, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION AND HAS NOT USED THE IMPLANTABLE NEUROSTIMULATOR (INS) FOR OVER 8 MONTHS AND THE LAST SUCCESSFUL RECHARGE WAS BETWEEN 6 TO 12 MONTHS AGO. IT WAS REPORTED IN (B)(6) 2013 THAT THE MANUFACTURER REPRESENTATIVE MET WITH THE PATIENT LAST MONTH ((B)(6) 2013) AND THE INS WAS FOUND TO BE OVERDISCHARGED. TWO HOURS WERE SPENT AT THE HEALTHCARE PROVIDER'S (HCP) OFFICE DOING A PHYSICIAN MODE RECHARGE (PMR) WITHOUT SUCCESS. THE HCP WAS GOING TO GET AUTHORIZATION TO DO A BATTERY REPLACEMENT. IT WAS NOTED THAT THIS APPEARED TO BE A COMPLIANCE ISSUE. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS UNAVAILABLE AT THE DATE OF THIS REPORT. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT SAW THE POOR COMMUNICATION SCREEN ON THE PATIENT PROGRAMMER AND THE RE-POSITION SCREEN ON THE RECHARGER. IT WAS NOTED PATIENT ATTEMPTED TO CHARGE, BUT ¿IT DID NOT TURN ON.¿ IT WAS STATED AN OVERDISCHARGE WAS SUSPECTED SINCE THE LAST SUCCESSFUL RECHARGING SESSION WAS 6-12 MONTHS AGO. IT WAS NOTED IT HAD BEEN OVER 8 MONTHS SINCE PATIENT HAD USED STIMULATION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165077 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention