BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2955722 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02534
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    January 29, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377760, LOT# N0030800, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 355029, LOT# N0047451, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED, THE PATIENT HAD HER IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED. IT WAS STATED, IT TOOK A COUPLE HOURS TO TRICKLE CHARGE HER BATTERY AFTER BEING OVER DISCHARGED FOR OVER A YEAR. THE PATIENT DID NOT LIKE RECHARGING SO HER NEW INS WAS NON-RECHARGEABLE. REPORTEDLY THE PATIENT IS DOING WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS GOING TO BE REPLACED THE WEEK FOLLOWING THE CALL. IT WAS STATED THAT THE PATIENT HAD SECOND OVERDISCHARGE EVENT. THE PATIENT REPORTEDLY DID AN ANTENNA LOCATE ASSESSMENT AND PHYSICIAN MODE RECHARGE. AS A RESULT, THE PATIENT WAS ABLE TO RECHARGE THE INS REGULARLY. IT WAS NOTED THAT THERE WERE TELEMETRY ISSUES. IT WAS STATED THAT THE PATIENT HAD BEEN CHARGING FOR THREE HOURS BUT THE FIRST QUARTER OF THE INS STILL WAS NOT CHARGED. IT WAS NOTED THAT THERE WERE 9 COUPLING BARS AND THE DEVICE COULD NOT BE READ WITH THE PHYSICIAN PROGRAMMER. THE PATIENT REPORTEDLY PLANNED TO NOT USE STIMULATION UNTIL REPLACEMENT. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58945 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention