BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3203494 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-01406
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    July 2, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT FOR THE DEVICE WAS NOT TAKING CARE OF THE PAIN. THE PAIN WAS GRADUALLY GETTING WORSE. THE PATIENT HAD ACUTE PAIN AT THE LOW BACK AND HIPS. THE PATIENT HAD MRI ON (B)(6) 2012 AND THE PATIENT STATED IF THE MRI FOUND SOMETHING WRONG THE PATIENT WOULD CONSIDER HAVING THE PUMP EXPLANTED. THE LAST REFILL WAS ON (B)(6) 2012. THE PATIENT STATED THERE WERE PROBLEMS WITH HER BACK ¿RELATED TO WHERE THE CATHETER IS¿ THE HEALTH CARE PROVIDER INDICATED THAT ON THE REFILL DATE, THE PATIENT NEVER MENTIONED ABOUT THE EVENT THAT SHE REPORTED. THE MRI SHOWED THE PUMP WAS NO ANOMALY. THE PATIENT STATED THE HEALTH CARE PROVIDER ¿CLEANED 4<(>&<)>5 OUT.¿ THE PATIENT WAS UNSURE STATING IT WAS HER LOW BACK. THE PATIENT STATED THAT ¿WHATEVER WAS IN THAT AREA WAS HITTING THE SCIATIC NERVE <(>&<)> ONCE THE HCP CLEANED THEM OUT SHE STOPPED HAVING THE LEG PAIN.¿ THE PATIENT STATED ¿SHE HAD SOMETHING THAT KEEPS COMING OUT DOWN THERE IN THE LUMBAR AREA.¿ THE PATIENT SATED WHEN THE AREA PUSHES OUT IT CAUSES PAIN DOWN TO HER KNEES. THE PATIENT WAS NOT SURE WHAT THE CAUSED THE PUSHED OUT AREA. THE PATIENT STATED SHE HAD SOME ISSUES WITH HER PELVIS. THE PATIENT STATES WHEN THERAPIST ADJUSTED HER BACK THERAPIST WERE ABLE TO GET HER PELVIS PAIN FREE. THE PATIENT¿S HIP PAIN WAS CHECKED BY HEALTH CARE PROVIDER IN ST LOUIS AND INFORMED THE PATIENT SHE HAD SOME HIP DAMAGE BUT NOT ENOUGH TO WARRANT THE PAIN THE PATIENT WAS EXPERIENCING. THE DAMAGE WAS NOT SIGNIFICANT ENOUGH FOR HIP REPLACEMENT. MORPHINE, BACLOFEN AND CLONIDINE WERE DELIVERED IN THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302301 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR