BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3172698 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10436
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 31, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3 7754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37761, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS RECHARGING MORE THAN EXPECTED. THE PATIENT HAD BEEN IMPLANTED FOR A WEEK AND THE BATTERY WAS FULLY CHARGED AT IMPLANT. THE BATTERY WENT ¿DEAD¿ WITHIN 4 DAYS. THE PATIENT RECHARGED IT, BUT IT ONLY LASTED 2 DAYS. THE BATTERY WAS RECHARGED AGAIN ON THE DAY OF THIS REPORT. THE ELECTRODE IMPEDANCES RANGED FROM 2000-2200. IT WAS LATER REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS DEPLETING IN A COUPLE OF DAYS. THERE WERE 6-8 COUPLING BARS DURING RECHARGE. RECHARGE INTERVAL ESTIMATION GAVE A RANGE OF 6 TO 7.5 DAYS FOR RECHARGING. IT WAS LATER REPORTED THAT IMPEDANCE TESTING WAS DONE AND ALL WERE WITHIN RANGE. NO MALFUNCTIONS WERE SEEN AND THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE PATIENT BEGAN ¿CYCLING.¿ THE PATIENT WAS DOING MUCH BETTER AND WAS ABLE TO STRETCH THE RECHARGE INTERVAL TO SEVEN DAYS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273491 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR