BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2489185 · Received March 13, 2012

    Report

    Report Number
    3004209178-2012-01523
    Event Type
    Malfunction
    Date Received
    March 13, 2012
    Report Date
    February 20, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS
    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

    CONCOMITANT MEDICAL PRODUCTS: LEAD MODEL 3777-75 SERIAL# (B)(4) IMPLANTED: (B)(6) 2009 EXPLANTED: NA; LEAD MODEL 3487A-56 LOT# V250886 IMPLANTED: (B)(6) 2009 EXPLANTED: NA; LEAD MODEL 3487A-56 LOT# V208747 IMPLANTED: (B)(6) 2009 EXPLANTED: NA; PROGRAMMER MODEL 37743 SERIAL# (B)(4); RECHARGER MODEL 37752 SERIAL# (B)(4); EXTENSION MODEL 3708220 SERIAL# (B)(4) IMPLANTED: (B)(6) 2009 EXPLANTED: NA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED INDICATED THAT THE CAUSE OF THE EVENT WAS AN OVER DISCHARGED BATTERY. IMPEDANCES WERE FOUND TO BE OKAY. THERE WAS NO HOSPITALIZATION, INJURY TO PATIENT OR SURGERY SCHEDULED. THE PATIENT WAS INSTRUCTED BY THEIR PHYSICIAN TO CHARGE ON A REGULAR BASIS TO AVOID A REOCCURRENCE OF OVER DISCHARGE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOR THE PAST TWO MONTHS, THE PATIENT HAD NOT FELT STIMULATION. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS UNABLE TO BE INTERROGATED WITH A PHYSICIAN PROGRAMMER, RECHARGER OR PATIENT PROGRAMMER. A PHYSICIAN MODE RESET WAS UNSUCCESSFULLY ATTEMPTED, DUE TO POOR COMMUNICATION WITH THE INS. THE PATIENT ALSO INDICATED THAT THEY COULD FEEL THE INS MOVE AROUND IN IMPLANT POCKET. X-RAYS WERE SCHEDULED TO DETERMINE IF THE INS HAD FLIPPED. ADDITIONAL INFORMATION HAD 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 MDT PUERTO RICO OPERATIONS 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR