BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3231206 · Received July 17, 2013

    Report

    Report Number
    3004209178-2013-11882
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    June 24, 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
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37092, LOT# 267690001, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS ¿MASS EFFECT ON CORD.¿ IMAGING WAS PERFORMED ON (B)(6), 2013, AND IT WAS NOTED THERE WAS AN EPIDURAL HEMATOMA. IT WAS NOTED THERE WAS CONTINUED PARESTHESIA. PATIENT OUTCOME WAS NOTED AS SERIOUS I NJURY/ILLNESS ¿ ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE DATE OF THIS REPORT, A LEAD REVISION WAS CONDUCTED DUE TO INADEQUATE PARAESTHESIA. IT WAS NOTED THERE WAS STIMULATION IN THE WRONG LOCATION. IT WAS NOTED THAT TWO PERCUTANEOUS LEADS WERE REPLACED WITH A SURGICAL PADDLE. IT WAS NOTED THAT THE LEAD WAS CONNECTED TO THE EXISTING GENERATOR. IMPEDANCES WERE WITHIN NORMAL LIMITS. IT WAS NOTED THAT STIMULATION WAS NOT TURNED ON. IT WAS FURTHER NOTED THAT THE PATIENT CONVERSED WELL IN THE POSTOPERATIVE AREA AND WAS INSTRUCTED NOT TO TURN ON STIMULATION UNTIL THE 10 DAY POSTOPERATIVE APPOINTMENT. LATER THAT DAY, THE MANUFACTURING REPRESENTATIVE WAS INFORMED THAT THE PATIENT HAD BEEN ADMITTED TO THE EMERGENCY ROOM DUE TO A REPORTED LOSS OF SENSATION IN THE LOWER EXTREMITIES. IT WAS NOTED THAT A COMPLETE EXPLANT WAS ANTICIPATED. THE FOLLOWING DAY, THE ENTIRE SYSTEM HAD BEEN EXPLANTED. IT WAS NOTED THE PATIENT HAD NOT REGAINED SENSATION. COMPLICATIONS INCLUDED PARALYSIS OF THE LOWER EXTREMITIES. HOSPITALIZATION OCCURRED AS A RESULT OF THE EVENT. IT WAS STATED AS OF (B)(6) 2013, THE PATIENT WAS SLOWLY REGAINING SENSATION IN THE LOWER EXTREMITIES. 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
    330554 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R