BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3271222 · Received August 8, 2013

    Report

    Report Number
    3004209178-2013-12966
    Event Type
    Malfunction
    Date Received
    August 8, 2013
    Report Date
    July 16, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 377745, LOT# V011334, IMPLANTED: (B)(6) 2007, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT 1 TO 2 WEEKS PRIOR TO THIS REPORT WHEN THE PATIENT HAD TRIED TO CHANGE PROGRAMS HE HAD NOTICED A DIFFERENCE IN STIMULATION SENSATION AND A LEAD FRACTURE WAS SUSPECTED. PATIENT HAD 6 PROGRAMS AND USED PROGRAM C ABOUT 90% OF THE TIME. IT WAS NOTED THAT THE WEEK PRIOR TO THIS REPORT THE PATIENT HAD CHANGED TO PROGRAM A AND B WHICH HE WOULD DO WHEN THE ¿PAIN GETS BAD.¿ WHEN THE PATIENT WOULD MOVE 1 MM, HE WOULD ¿JUST JUMP¿ FROM THE SENSATION. IT WAS FURTHER NOTED THAT THE PATIENT THOUGHT HE WAS MORE PRONE TO LEAD FRACTURE ISSUES BECAUSE HE WAS THIN AND THE LEADS STUCK OUT OF HIS SKIN. IT WAS NOTED THE PATIENT GOES IN EVERY 3 MONTHS FOR CHECKUPS. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372614 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR