BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2943469 · Received February 5, 2013

    Report

    Report Number
    3004209178-2013-01291
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Report Date
    January 23, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, 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, PATIENT; PRODUCT ID 37092, LOT # 221340003, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY; PRODUCT ID 3550-39, LOT # N213345, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH LEADS OF THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) HAD MIGRATED FOLLOWING A FALL (NO DETAILS PROVIDE D). IT WAS NOTED THAT ONE OF THE LEADS HAD MIGRATED DOWN TO T8 AND THE OTHER LEAD DOWN TO T10. IN ADDITION, IT WAS REPORTED THAT THE INS COMPONENT HAD MOVED FORWARD TOWARD THE SPINE. THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2013 WITH THEIR PHYSICIAN FOR AN INJECTION. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT NO LONGER HAD CONCERNS WITH THEIR DEVICE OR THERAPY. IT WAS STATED THE PATIENT RECEIVED ASSISTANCE FROM THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE ON (B)(6) AND THEIR CONCERNS WERE RESOLVED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47630 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