BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2882331 · Received December 20, 2012

    Report

    Report Number
    3004209178-2012-12112
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    November 30, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PROGRAMMER WAS COMPLETELY BLANK EVEN AFTER THE BATTERIES WERE REPLACED. IT WAS ALSO NOTED THAT BOTH THE CHARGER AND THE RE-PROGRAMMER "DIDN'T WORK." PATIENT ATTEMPTED TO "RECHARGE EVERY DAY" AND REPORTED THE PROBLEMS BEGAN 6 MONTHS PRIOR. PATIENT DECLINED TROUBLESHOOTING AND WANTED A REPRESENTATIVE AT THEIR APPOINTMENT. FOLLOW UP WAS UNCLEAR AS ALL BOXES WERE CHECKED. PATIENT DID HAVE CONCERNS WITH THEIR DEVICE OR THERAPY. ALSO NOTED WAS THE PATIENT RECEIVED ASSISTANCE FROM THEIR DOCTOR OR MEDTRONIC REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. ALSO NOTED THERE WOULD BE A REPLACEMENT ON (B)(6) 2012. ALSO NOTED WAS THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WERE WORKING WITH THEIR DOCTOR OR REPRESENTATIVE. ALSO NOTED WAS PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT HAVE NOT SOUGHT FURTHER HELP. 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 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