BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3872627 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-11573
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    May 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    GZB
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. 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. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-29, LOT# N424210, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 97714, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4). (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NOTICED THE DAY PRIOR TO THE REPORT THAT THE PULSES WERE STARTING AND STOPPING AND WERE SLOW. IT WAS NOT THE CONSTANT FAST VIBRATION THAT SHE WOULD FEEL. SHE DID NOT HAVE BREAKTHROUGH PAIN, HOWEVER. THE PATIENT HAD 2 STIMULATORS, ONE FOR EACH FOOT. THE PATIENT WAS LYING ON HER BACK AND HAD HER KNEES RAISED. SHE COULD FEEL STIMULATION. HOWEVER, WHEN SHE PUT HER LEG STRAIGHT DOWN AND LAY FLAT, SHE COULD NOT FEEL IT. THE PATIENT NEVER FELT IT START AND STOP WITHOUT 1-2 SECOND PAUSES. THE PATIENT WAS ADVISED TO CONTACT HER PHYSICIAN. THE PATIENT HAD VIBRATION IN THE RIB AND HIP WHICH SHE NOTICED THE DAY PRIOR AND DAY OF THE REPORT. OF NOTE, THE PATIENT HAD A ¿SMOOTH SLIDE¿ A WEEK PRIOR AT THE PLAYGROUND AND SHE CAUGHT HERSELF. THERE HAD BEEN NO CHANGES MADE EXCEPT DECREASING OR INCREASING STIMULATION. IT WAS FURTHER REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS BUT WORKING WITH HER PHYSICIAN AND/OR COMPANY REPRESENTATIVE. THE PATIENT HAD AN UPCOMING APPOINTMENT FOR (B)(6) 2014. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349635 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) GZB MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR