BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 4611012 · Received March 17, 2015

    Report

    Report Number
    3004209178-2015-04906
    Event Type
    Injury
    Date Received
    March 17, 2015
    Report Date
    February 24, 2015
    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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 748910, SERIAL# (B)(4), IMPLANTED: 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 748910, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID; 3093-28, LOT# V072737, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3093-28, LOT# V073596, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED URGE INCONTINENCE AND FREQUENCY. THEY LEAKED TWO TO THREE TIMES A DAY. THEY DID NOT ALWAYS FEEL EMPTY, BUT WOULD THEN HAVE A BOWEL MOVEMENT. WHEN THE PATIENT PUT OFF VOIDING, THEY WOULD LEAK MORE. THEY WOULD LEAK ON THEIR WAY TO THE BATHROOM. THE PATIENT ALSO EXPERIENCED STRESS INCONTINENCE. THEY HAD TURNED THEIR STIMULATION OFF AND ON AGAIN. THE PATIENT ALSO EXPERIENCED LEG AND HIP PAIN, WEIGHT LOSS, BLURRY VISION, HEARING LOSS, LEFT CALF EDEMA, SWOLLEN ANKLES, ABDOMINAL PAIN, DIARRHEA, NUMBNESS, TINGLING, ACUTE CYSTITIS, AND ATROPHIC VAGINITIS. IT WAS REPORTED THE PATIENT¿S THERAPY HAD NOT WORKED FOR THEM FOR ONE AND A HALF YEARS. THEY HAD A GRADUAL LOSS OF STIMULATION. THE PATIENT HAD A BLADDER INFECTION. REPROGRAMMING COULD NOT BE PERFORMED. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE HEALTH CARE PROVIDER ASKED WHEN THE PATIENT'S DEVICE WAS LAST INTERROGATED AND WHEN IT SHOULD BE INTERROGATED NEXT. THE REPORTER STATED THE PATIENT DID NOT FEEL AS THOUGH HER DEVICE WAS WORKING. THE REPORTER WAS NOT COMFORTABLE WITH WORKING THE PATIENT'S EXTERNAL EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181325 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention