BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3241561 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12128
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    June 25, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3998, LOT# LB0011, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD; PRODUCT ID 3487A, LOT# J0417774V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD; PRODUCT ID 74002, LOT# N227416, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ADAPTER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER; PATIENT PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION; PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708320, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS GOING TO HAVE A REVISION IN TWO DAYS, WHEREIN HER DEVICE THAT WAS PREVIOUSLY EXPLANTED WAS GOING TO BE REPLACED. IT WAS NOTED THAT IN REVIEWING X-RAYS, THE PATIENT'S SURGICAL LEAD APPEARED RETROGRADE AND ONE OF THE "TAILS" WAS EXPOSED AND NOT ATTACHED TO ANYTHING. THE OTHER TAIL AND THE PATIENT'S PERCUTANEOUS LEAD APPEARED TO BE ATTACHED TO THE EXTENSIONS. IT WAS NOTED THAT WHEN THE PATIENT'S DEVICE WAS REMOVED, THE EXTENSIONS WERE CUT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT WHEN THE PHYSICIAN OPENED THE SITE TO REPLACE THE DEVICE, HE FOUND THE EXTENSIONS WERE CUT AND ONE LEAD FROM THE PADDLE LEAD WAS BROKEN OFF OR CUT DURING THE INCISION. THE PHYSICIAN HOOKED UP THE NEW DEVICE TO THE PATIENT'S PERCUTANEOUS LEAD THAT WAS STILL INTACT AND IMPEDANCES WERE SIGNIFICANTLY OVER. IT WAS NOTED THAT IMPEDANCES WERE RETESTED WITH DIFFERENT AMPLITUDES AND REFERENCES TO TRY TO OBTAIN SOME NORMAL READINGS. THE PHYSICIAN THEN CLOSED THE INCISIONS. THE PATIENT WAS SEEN THE NEXT DAY IN THE PHYSICIAN'S OFFICE AND THE RESULTS WERE THE SAME, WITH NO STIMULATION FROM THE SYSTEM DUE TO HIGH IMPEDANCES. IT WAS NOTED THAT THE PHYSICIAN HAD THOUGHT THE BEST COURSE OF ACTION WAS TO REPLACE THE DEVICE AND SEE HOW THE SYSTEM WORKED. THE UNFORTUNATE EVENT WAS THE REMAINING LEAD AND EXTENSION WERE BROKEN/CUT DURING OPENING. THE PHYSICIAN SPOKE TO THE PATIENT AND THEY WERE GOING TO DECIDE TOGETHER WHAT COURSE OF ACTION WILL BE TAKEN. IT WAS NOTED THAT THE PATIENT WAS NOT RECEIVING THERAPY AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340689 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR