BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4695544 · Received April 15, 2015

    Report

    Report Number
    3004209178-2015-07312
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Report Date
    March 25, 2015
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3887-33, LOT # J0343933V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 3888-33, LOT # J0340513V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 3708360, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3708360, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 377645, LOT # V002451, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 377645, LOT # V002451, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37712, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING HER DEVICE. THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2015 AND SHE WAS GOING TO WORK WITH HER DOCTOR TO RESOLVE THE PROBLEM THAT SHE WAS HAVING WITH THE DEVICE THAT ALLOWED HER TO ADJUST THE STIMULATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) ON THE LEFT SIDE SEEMED LIKE IT WAS NOT IN ITS ORIGINAL POSITION AT IMPLANT. THE INS WAS ONLY 1 FINGER AWAY FROM THE PATIENT¿S RIB AND WHEN SHE BENT OVER, IT WAS TOUCHING HER RIB AND FELT TIGHT. THE ONE ON THE RIGHT SEEMED FINE AND WAS LIKE 3 TO 3.5 FINGERS BELOW THE RIB. NO THERAPY EFFICACY ISSUE, JUST PLACEMENT. THE PATIENT WAS ALSO CHARGING MORE THAN EXPECTED. THE RECHARGING INTERVAL SEEMED TO HAVE INCREASED. EACH BATTERY TOOK 4 TO 4.5 HOURS TO CHARGE. HOWEVER, IT WAS NOTED THAT THE PATIENT WAITED UNTIL IT WAS EMPTY BEFORE RECHARGING. NO INTERVENTIONS OR OUTCOME WERE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250410 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