BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2821470 · Received November 6, 2012

    Report

    Report Number
    3004209178-2012-09962
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Report Date
    October 8, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS EXPERIENCING "SHOCK WAVES ALL UP AND DOWN" HER LEG. THE PATIENT DID NOT HAVE A PATIENT PROGRAMMER TO ADJUST THE STIMULATION, AND DID NOT THINK SHE HAD RECEIVED ONE. THE PATIENT HAD RECEIVED ONE AND A REVIEW OF THE PROGRAMMER WAS GIVEN TO THE PATIENT THE DAY AFTER IMPLANTATION. IT WAS LATER STATED THAT THE PROGRAMMER BOX WAS EMPTY AT RECEPTION. THE PATIENT HAD MEMORY ISSUES DUE TO CHRONIC PAIN, AND WAS REPORTED TO HAVE HAD DEMENTIA. IT WAS REPORTED THE PATIENT HAD "STAPLES ALL UP AND DOWN" HER BACK, AND WAS NOT AWARE WHY THE HEALTH CARE PROVIDER (HCP) HAD DONE THAT. THE PATIENT THOUGHT SHE "MAY HAVE LEFT AGAINST MEDICAL ADVICE". THE PATIENT WAS ALSO FEELING STIMULATION ON THE WRONG SIDE OF THE BODY. THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR 2 DAYS LATER WITH A PHYSICIAN. ADDITIONAL INFORMATION RECEIVED 2 DAYS LATER REPORTED THE PATIENT COULD FEEL STIMULATION ON THE RIGHT LEG, BACK, HIP, AND FOOT. THE PATIENT HAD A BACK SURGERY THE SAME MONTH OF IMPLANTATION, WHICH WAS DESCRIBED AS A "LARGE BACK SURGERY", AND THE STAPLES WERE MENTIONED AT THE SAME TIME. THE PATIENT THOUGHT SHE HAD FALLEN IN THE HOSPITAL AFTER THE IMPLANT, AND THOUGHT HER LEG WAS FRACTURED. IT WAS NOTED THE PATIENT HAD URINATED HERSELF AFTER IMPLANT. ADDITIONAL INFORMATION RECEIVED APPROXIMATELY 3 WEEKS LATER REPORTED THE PATIENT WAS GIVEN A PATIENT PROGRAMMER AND A REVIEW OF HOW TO USE THE DEVICE. THE PATIENT HAD NOT BEEN HEARD BACK FROM SINCE RECEIVING THE PROGRAMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1