BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3844155 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09999
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Report Date
    May 13, 2014
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER. PRODUCT ID: 37083-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37083-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3888-33, LOT# J0455224V, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-33, LOT# J0455224V, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 37083-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37083-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID 3888-33, LOT# J0455224V, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT SINCE THEY HAD LOST WEIGHT ¿YOU COULD SEE THE IMPLANTABLE NEUROSTIMULATOR (INS), IT STICKS OUT A FOURTH OF AN INCH AND YOU CAN MOVE THE WIRE.¿ THE PATIENT NOTED THAT THEY LOST WEIGHT DURING THE TIME THAT THEY HAD A WHIPPLE PROCEDURE IN 2011 OR 2012 BECAUSE OF THE PATIENT¿S ABNORMAL PANCREAS. IT WAS NOTED THAT ¿THEY REROUTED THE STOMACH AND HAD A FEEDING TUBE.¿ THE PATIENT NOTED THAT THEY WERE ¿VERY SICK¿ AT THAT TIME. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD NOT USED THEIR DEVICE SINCE 2011. THE PATIENT HAD A LOT OF MEDICAL PROBLEMS. THE PATIENT COULD MOVE THEIR IMPLANTABLE NEUROSTIMULATOR (INS) AROUND AND THAT IT STILL PUSHED UP AND HURT. AFTER THE PATIENT'S FIRST KNEE SURGERY IN 2009, THE BATTERY KEPT POPPING UP. OMITTED INFORMATION FROM (B)(4) - OVERDISCHARGE AND (B)(4) - INS REPLACEMENT AND (B)(4) - INS REPLACEMENT, 2006 SINCE THEY ARE UNRELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322007 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR