BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4255019 · Received November 17, 2014

    Report

    Report Number
    3004209178-2014-21667
    Event Type
    Injury
    Date Received
    November 17, 2014
    Report Date
    October 28, 2014
    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 PRODUCTS: PRODUCT ID 377760, LOT# V004734, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 377760, LOT# V003345, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS IN ITS THIRD OVERDISCHARGE. IT WAS 6 MONTHS SINCE THE PATIENT LAST HAD STIMULATION. THE PATIENT WOULD TRAVEL TO ANOTHER COUNTRY AND DID NOT HAVE GOOD POWER SOURCE FOR CHARGING. THE STIMULATION COVERAGE WAS GOOD WHEN IT LAST WORKED. IT WAS NOTED THAT THE HEALTHCARE PROVIDER (HCP) WAS GOING TO REPLACE THE BATTERY ON (B)(6) 2014. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD THE REPLACEMENT DONE ON 2014-(B)(6). HE WAS RECEIVING EFFECTIVE THERAPY POST REPLACEMENT. THE EXPLANTED DEVICES WOULD NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. IT WAS NOTED THAT THERE WAS NO MALFUNCTION WITH THE OLD DEVICE; THE PATIENT HAD ADMITTED THAT HE TRAVELED TO THE DOMINICAN REPUBLIC OFTEN AND JUST WAS NOT ABLE TO CHARGE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742474 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention