BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2880151 · Received December 19, 2012

    Report

    Report Number
    3004209178-2012-12059
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Report Date
    November 29, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7495-66, SERIAL # (B)(4), IMPLANTED: (B)(6) 1999, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-33, LOT # L67150, IMPLANTED: (B)(6) 1999, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOCATION OF A PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN BLEEDING FOR THE THREE DAYS PRIOR TO REP ORT AND WAS "VERY TENDER TO THE TOUCH." IT WAS ALSO STATED THAT THE PATIENT EXPERIENCED A SHOCKING SENSATION WHEN THE INS AREA WAS TOUCHED WHICH WOULD TRAVEL FROM INS SITE UP TO THE BACK. IT WAS STATED THAT THE LEADS HAD COME LOOSE FROM THE INS AND WERE "COMING OUT OF THE SKIN WHERE THE PATIENT WAS ABLE TO TOUCH THE LEADS." THE PATIENT WAS ADVISED BY HER PHYSICIAN TO "COME IN RIGHT AWAY." APPROXIMATELY ONE WEEK LATER, IT WAS REPORTED THAT THE PATIENT COULD NOT FEEL ANY STIMULATION WHICH HAD BEGUN ABOUT ONE YEAR PRIOR. STIMULATION WAS TURNED UP TO 10V AND THE PATIENT STILL COULD NOT FEEL STIMULATION. ELECTRODE IMPEDANCES WERE BETWEEN 2800-4600 OHMS, EXCEPT #3 WHICH WAS 8218 OHMS. IT WAS DISCUSSED THAT THERE COULD BE A POSSIBLE FRACTURE OR FLUID BREACH. APPROXIMATELY ONE WEEK LATER, IT WAS REPORTED THAT X-RAYS, IMPEDANCE TESTING, AND REPROGRAMMING WERE ALL DONE WITH NO CONCLUSIONS MADE. IT WAS STATED THAT THERE WERE DEFINITELY MALFUNCTIONS SEEN (STIMULATION NOT WORKING) BUT NO CAUSE HAD BEEN DETERMINED. IT WAS STATED THAT THE PATIENT WILL LIKELY HAVE A LEAD REVISION SURGERY WHERE ALL THE COMPONENTS WOULD BE CHECKED INTRA-OPERATIVELY, BUT NO DATE WAS SET. FURTHER INFORMATION HAS BEEN REQUESTED, HOWEVER, NONE WAS AVAILABLE AT THE TIME OF THIS REPORT. IF MORE INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    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