BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3983841 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-14018
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 14, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE PATIENT GOT IN THE CAR, JUST BELOW THE BRA IN THE BACK, ¿ALL OF SUDDEN IT HITS THERE AND THEN GOES RIGHT AROUND THE RIBS TO THE FRONT AND IT JUST NAILED HER AND HURTS LIKE CRAZY.¿ IT WAS NOTED THAT IT WOULD ¿DO THAT FOR A WHILE AND IT JUST KNOCKED THE BREATH RIGHT OUT OF HER.¿ THE PATIENT STATED THAT THIS HAPPENED TWICE. THE PATIENT ALSO STATED THAT THIS HAD OCCURRED A ¿COUPLE OF TIMES. THE PATIENT NOTED THAT SHE HAD ¿BEEN ABLE TO GRIN AND BEAR THROUGH IT BECAUSE SHE WAS STILL USED TO ALL THAT PAIN.¿ THE PATIENT ALSO STATED THAT WHILE SHE HAD STIMULATION ON ¿IT SEEMED LIKE THROUGHOUT THE DAY IT KIND OF GAINED MOMENTUM OR GOT STRONGER.¿ IT WAS NOTED THAT IT ¿SEEMED TO GET STRONGER¿ AND THE PATIENT WAS WONDERING IF IT WAS ALSO CAUSING A TENSION HEADACHE. IT WAS NOTED THAT ¿IT¿ WAS IN THE LOW BACK AS WELL. THE PATIENT NOTED THAT ¿ALL OF THIS HAD BEEN GOING ON SINCE IMPLANT AND ALL OF A SUDDEN JUST STARTED.¿ THE PATIENT ASKED IF ¿ALL OF THIS¿ WOULD BE HAPPENING IF THE PATIENT HAD A ¿BAD¿ VERTEBRA. THE PATIENT STATED THA T SHE ¿MUST HAVE A BAD VERTEBRAE OR SOMETHING.¿ THE PATIENT NOTED THAT SHE TRIED ADJUSTING THE STIMULATION TO SEE IF IT WOULD RESOLVE THE ISSUE BUT IT HAD NOT. THE PATIENT MENTIONED THAT SHE HAD THE DEVICE IMPLANTED FOR THREE WEEKS AS OF THE DATE OF THIS REPORT. THE PATIENT WAS REDIRECTED TO THE HEALTHCARE PROFESSIONAL (HCP). ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461093 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR