BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2823434 · Received November 8, 2012

    Report

    Report Number
    3004209178-2012-10028
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Report Date
    October 11, 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 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID 3778-60, SERIAL# (B)(4), 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. PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE COUPLING ISSUES BETWEEN THE PATIENT'S RECHARGER AND THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WITH THE MAXIMUM COUPLING ACHIEVED BEING 2 BARS SHADED ON THE RECHARGER. THE ANTENNA LOCATOR (AL) FEATURE WAS THEN USED TO FACILITATE COUPLING WITH NO SUCCESS (THE HIGHEST NUMBER SEEN WAS 66 ALTHOUGH COUPLING REMAINED AT 2 BARS). THE COUPLING ISSUE WAS REPORTED AS BEEN OCCURRING SINCE (B)(6) 2012. IT WAS NOTED THAT THE PATIENT WAS THIN AND THAT THE INS WAS NOT FELT TO BE TOO DEEP. ADDITIONAL INFORMATION RECEIVED REPORTED THAT X-RAYS TAKEN SHOWED THAT THE LEADS WERE COMING OUT ON THE LEFT SIDE INSTEAD OF THE RIGHT INDICATING (AND CONFIRMING) THAT THE INS WAS FLIPPED. FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PHYSICIAN MANUALLY FLIPPED THE INS RIGHT-SIDE UP AT WHICH TIME THEY WERE ABLE TO GET 8 COUPLING BARS WITH THE RECHARGER. THE PATIENT MAY NEED A REVISION IN THE FUTURE IF THE PHYSICIAN IS UNABLE TO ANCHOR THE INS IN THE CORRECT POSITION. TO DATE, THE REVISION HAS NOT OCCURRED OR BEEN SCHEDULED. AT THE TIME OF THIS REPORT, THE PATIENT WAS ABLE TO RECEIVE EFFECTIVE THERAPY AND WAS ABLE TO RECHARGE NORMALLY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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