BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3973897 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13859
    Event Type
    Injury
    Date Received
    August 1, 2014
    Report Date
    July 10, 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
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LEAD MIGRATION. IT WAS NOTED THAT ACTIONS REQUIRED AS A RESULT OF THE EVENT WAS REVISION. IT WAS NOTED THAT THE PATIENT REPORTED THAT PRIOR TO PHYSICAL THERAPY, HE HAD GREAT COVERAGE. IT WAS NOTED THAT AFTER PHYSICAL THERAPY, THE PATIENT¿S STIMULATION HAD CHANGED. IT WAS NOTED THAT X-RAYS WERE TAKEN AT UNKNOWN DATES AND SHOWED 3 MM MIGRATION OF THE LEADS. IT WAS NOTED THAT THE PATIENT REQUESTED A REVISION OF THE LEADS. IT WAS NOTED THAT THE LEADS WERE MOVED UP FROM T8 TO T7. IT WAS NOTED THAT THE PATIENT WAS PROGRAMMED IN RECOVERY WITH GOOD COVERAGE OF PAIN AND HAPPY WITH THE RESULTS. IT WAS NOTED THAT THERE WAS NO ANCHOR ISSUE OR SYSTEM ISSUE NOTED AT REVISION. IT WAS NOTED THAT DIAGNOSTIC TESTING INCLUDED IMPEDANCE TESTING, X-RAYS, AND REPROGRAMMING. IT WAS NOTED THAT THE RIGHT LEAD DID NOT MIGRATE AT ALL. IT WAS NOTED THAT THE PATIENT¿S STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY. IT WAS NOTED THAT SYMPTOMS INCLUDED LESS THAN 50 PERCENT THERAPY RELIEF. IT WAS NOTED THAT THE LOCATION OF THE SYMPTOM WAS LOW BACK AND POSTERIOR BILATERAL LOWER EXTREMITIES. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450830 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention