BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3122868 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-08006
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 8, 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 PRODUCTS: PRODUCT ID 3778, LOT# V370077028, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3778, LOT# V490712036, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED TELEMETRY ISSUES AND AN INS OVERDISCHARGE WAS SUSPECTED. THE LAST SUCCESSFUL RECHARGING SESSION WAS OVER 12 MONTHS AGO AND THE LAST TIME ANY STIMULATION WAS FELT WAS OVER 12 MONTHS AGO. PROBLEMS WITH RECHARGE COUPLING DUE TO THE PATIENT¿S WEIGHT WERE THE PRIMARY REASON FOR THE OVERDISCHARGE. THE HCP PLANNED TO REVISE THE INS LOCATION AS THE INS WAS IN THE PATIENT¿S STOMACH AREA AND IT HAD BEEN DIFFICULT TO RECHARGE. IT WAS UNKNOWN IF THE INS HAD BEEN PREVIOUSLY OVERDISCHARGED. IT WAS ALSO NOTED THAT THE HCP PLANNED TO CHECK THE LEADS DURING THE INS POCKET REVISION. 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
    224548 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 00048 YR Required Intervention