BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4024634 · Received August 20, 2014

    Report

    Report Number
    3004209178-2014-15613
    Event Type
    Injury
    Date Received
    August 20, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3888-56, LOT# V974781, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 97740, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 97754, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT REPORTED LOSS OF THERAPY AT A FOLLOW UP APPOINTMENT. IT WAS REPORTED THAT AFTER INTERROGATING THE SYSTEM, THE MANUFACTURER¿S REPRESENTATIVE NOTICED THAT 8 AND 11 HAD OUT OF RANGE IMPEDANCES. IT WAS STATED THAT THE PATIENT REPORTED FALLING DOWN ON HER BACK 5 TO 6 TIMES. IT WAS REPORTED THAT A REVISION WAS SCHEDULED FOR (B)(6). IT WAS NOTED THAT NO FURTHER DIAGNOSTICS HAD BEEN PERFORMED, BUT WOULD BE IN THE FUTURE. IT WAS STATED THAT IT WAS UNKNOWN WHETHER THE ISSUE WAS RESOLVED. THE PATIENT STATED THAT AFTER ONE OF THE FALLS SHE LOST COVERAGE FROM HER STIMULATION. IT WAS REPORTED THAT THE PATIENT WAS ALIVE WITH NO INJURY. IT WAS NOTED THAT THE PATIENT WALKED WITH A CANE AND HAD A LIMP DUE TO A FAILED KNEE REPLACEMENT, AND IT WAS NOTED THAT THE PATIENT HAD OVER 20 SURGERIES ON HER BACK, KNEE, AND HIP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS DOING WELL AFTER THE REVISION AND WAS GETTING GOOD COVERAGE. IT WAS NOTED THAT THE EXPLANTED LEADS WERE NOT TO BE SENT BACK TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502314 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention