BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME

    MDR report key: 2963787 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02708
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 28, 2013
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT "EXPERIENCED REAL STRONG STIMULATION IN HER LEFT LEG AND THEN SHE DIDN'T FEEL ANY STIMULATION." IT WAS STATED THAT AFTER THIS INCIDENT, THE PATIENT INCREASED THE AMPLITUDE OF HER DEVICE, BUT ONLY FELT THE STIMULATION IN HER BACK. IT WAS FURTHER INDICATED THAT THE PATIENT'S TARGET AREA WAS THEIR LEFT LEG AND LOWER BACK. THE PATIENT REPORTEDLY "DIDN'T FEEL ANY STIMULATION EVEN THOUGH THE STIMULATION WAS ON." THE PATIENT REPORTED NO FALLS OR TRAUMA AND THAT THEY HAD BEEN TAKING "ORAL MEDICATION." THE PATIENT WAS REDIRECTED TO THEIR HEALTH CARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROVIDER (HCP) REPORTED THAT THE PATIENT SAW THE HCP ON (B)(6) 2013. AT THAT TIME IT WAS DISCOVERED THAT THE LEAD WAS BROKEN ONE YEAR AND THREE MONTHS POST IMPLANT. THE PATIENT WAS DOING "WELL" UNTIL (B)(6) 2013. THE PATIENT DENIED ANY INJURY. THE PATIENT HAD GOOD STIMULATION COVERAGE AND WAS "HAPPY WITH THE PROGRESS AND SHE LIKED THE PAIN RELIEF" UNTIL (B)(6) 2013. THE PATIENT HAD PAIN IN HER LOW BACK, BILATERAL GROINS, LEFT POSTERIOR THIGH, CALF AND FOOT. THE PATIENT ALSO HAD TINGLING AND NUMBNESS IN HER LEFT FOOT. THE PATIENT FELT SLIGHT TENDERNESS IN THE BACK WHEN PALPITATED. IT WAS STATED THAT AN X-RAY SHOW THAT THE LEAD HAD "ROLLED UP IN THE SUBCUTANEOUS TISSUE OF HER SPINE". IT WAS REPORTED THAT DESPITE EXTENSIVE ANCHORING THE LEAD CAME OUT OF HER BACK AND NEEDED TO BE REPLACED. THE PATIENT HAD "EXCELLENT COVERAGE" AND WITHOUT IT THE PATIENT NOTICED A "BIG DIFFERENCE." IT WAS STATED THAT THE HCP PLANNED TO REMOVE THE OLD "WIRE" AND ATTEMPT TO PLACE TWO NEW ONES BECAUSE THE PATIENT HAD LOW BACK PAIN AND LEFT LEG PAIN AND BILATERAL HIP PAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE. IT WAS NOTED THAT THE NEXT APPOINTMENT DATE WAS (B)(6) 2013. IT STATED THAT THE "WIRES CAME LOOSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66797 RESTORE PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37701

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention