BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3072824 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06744
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    April 9, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3550-41, LOT# N172224, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: ACCESSORY: PRODUCT ID 3 9565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AN OVERDISCHARGE WAS SUSPECTED. IT WAS NOTED THE PATIENT HAD BEEN UNABLE TO USE STIMULATION FOR APPROXIMATELY ONE YEAR DUE TO HEALTH ISSUES. THE LAST TIME ANY STIMULATION WAS FELT WAS OVER 12 MONTHS PRIOR. IT WAS ALSO NOTED THE LAST SUCCESSFUL RECHARGING SESSION WAS OVER 12 MONTHS PRIOR. IT WAS NOTED THE PATIENT WORKED WITH THEIR REPRESENTATIVE FOR THREE HOURS AND THEY WERE UNABLE TO CHARGE THE STIMULATOR. ANTENNA LOCATE FEATURE WAS USED AND THE PATIENT WAS ABLE TO GET NUMBER'S IN THE 90'S BUT WAS UNABLE TO LOCATE THE INS. IT WAS LATER REPORTED THE PATIENT DID 4 PHYSICIAN MODE RECHARGES (PMR). IT WAS ALSO NOTED THE PATIENT HAD A PREVIOUS OVERDISCHARGE. THE REPRESENTATIVE PLANNED TO DO ANOTHER PMR IN THE OFFICE. IT WAS NOTED THERE WERE TELEMETRY ISSUES. IT WAS LATER REPORTED ANOTHER PMR WAS ATTEMPTED WITHOUT SUCCESS. THE PATIENT WILL DISCUSS WITH THEIR DOCTOR THE NEXT STEPS. IT WAS NOTED "THE DEVICE WILL NEED TO BE REPLACED" BUT IT HAD NOT BEEN SCHEDULED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE RECHARGER SCREEN HAD A "TEARDROP AND A CIRCLE WITH A DIAMOND IN THE MIDDLE" WHEN THE RECHARGER TRIED TO SYNC TO THE INS. IT WAS NOTED THAT THE PROGRAMMER SCREEN HAD A "LINE WITH A QUESTION MARK" WHEN THE PROGRAMMER TRIED TO SYNC WITH THE INS. IT WAS FURTHER REPORTED THAT THE PROGRAMMER WOULDN'T READ THE INS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173640 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