BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2882302 · Received December 20, 2012

    Report

    Report Number
    3004209178-2012-12109
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    December 3, 2012
    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

    PRODUCT ID 377760, LOT# N0037447, IMPLANTED: 2005 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 377760, LOT# N0040881, IMPLANTED: 2005 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED COUPLING AND COMMUNICATION ISSUES. IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS "COMPLETELY DEAD" COULD NOT CHARGE. IT WAS SUSPECTED THAT THE INS WAS IN AN OVER DISCHARGED STATE. IT WAS STATED THAT "IT IS GOING DOWNHILL" AND THE PATIENT COULD NO LONGER CHARGE THAT BATTERY. IT WAS LATER REPORTED THAT MULTIPLE ATTEMPTS WERE MADE TO TRICKLE CHARGE WITH NO SUCCESS. IT WAS STATED THAT THE PATIENT WILL HAVE THE BATTERY REPLACED THIS MONTH, BUT NO DATE WAS GIVEN. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REPLACEMENT WAS SCHEDULED FOR (B)(6) 2012. EIGHTEEN DAYS LATER, IT WAS REPORTED THAT THE PATIENT WAS SICK AND THEY WERE WAITING FOR HIM TO GET WELL BEFORE THE REPLACEMENT. 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
    1 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention