BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2770032 · Received October 3, 2012

    Report

    Report Number
    3004209178-2012-08825
    Event Type
    Injury
    Date Received
    October 3, 2012
    Report Date
    October 3, 2012
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3888-45, LOT# V851638, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT# V851638, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT# V851638, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT# V851639, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS POSSIBLE LEAD MIGRATION AND HIGH IMPEDANCE ON ONE ELECTRODE. A SURGICAL LEAD REVISION WAS SCHEDULED FOR (B)(6) 2012. AN X-RAY HAD BEEN TAKEN ON (B)(6) 2012 BUT NO FILM WAS PRESENT TO EVALUATE. NO REPROGRAMMING CHANGES WERE MADE AND THERE WAS NO PATIENT INJURY. A FEW DAYS LATER IT WAS REPORTED THAT THE PATIENT STILL HAD CONCERN REGARDING THEIR DEVICE OR THERAPY BUT THEY ARE WORKING WITH THEIR DOCTOR OR MANUFACTURE REPRESENTATIVE. THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. PATIENT FELT LIKE PROGRAMMING SETTINGS HAD CHANGED, DUE TO DIFFERENT COVERAGE FROM HIS FOUR LEADS. PATIENT COULD STILL FELL STIMULATION ON HIS LEFT SIDE BUT NOT ON HIS RIGHT. PATIENT DESCRIBED STIMULATION AS LEAD 1 WAS LOWER LEFT- UPPER LEFT, LEAD 2 WAS LOWER LEFT- UPPER LEFT, LEAD 3 WAS UPPER LEFT - LOWER RIGHT, AND LEAD 4 WAS LOWER LEFT. THE PATIENT FIRST NOTICED A CHANGE 2-3 PRIOR AFTER PLAYING WITH HIS GRANDKIDS AND RIDING HIS LAWN MOWER, BUT DOES NOT RECALL ANY FALLS THAT MAYBE HAVE BEEN ASSOCIATED WITH THE EVENT. 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 SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention