BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3050838 · Received April 10, 2013

    Report

    Report Number
    3007566237-2013-01198
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    March 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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708140, SERIAL# (B)(4). PRODUCT TYPE: EXTENSION: PRODUCT ID 3778-45, SERIAL# (B)(4). PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708140, SERIAL# (B)(4). PRODUCT TYPE: EXTENSION: PRODUCT ID 3778-45, SERIAL# (B)(4). PRODUCT TYPE: LEAD. MANUFACTURING SITE UPDATED TO FDA ESTABLISHMENT REGISTRATION # (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37743. PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL REVIEW INDICATED THAT PREVIOUSLY REPORTED INFORMATION IN MANUFACTURER REPORT # 3004209178-2013-07065 PERTAINS TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE PATIENT'S PAIN RETURNED IN THEIR LEGS ABOUT 2-3 WEEKS AGO. IT WAS NOTED THE LAST TIME PATIENT FELT STIMULATION WAS 2-3 WEEKS AGO. IT WAS ALSO NOTED THE PATIENT FELL ABOUT A MONTH AGO AND LANDED ON THEIR ARMS. THE PATIENT WAS ON PROGRAM ONE AT 4.7 VOLTS AND INCREASED TO 5 VOLTS AND REPORTED NOT FEELING STIMULATION. PATIENT TRIED ANOTHER PROGRAM AND WAS 8.2 VOLTS AND WAS NOT ABLE TO FEEL STIMULATION. PATIENT NOTED THIS WAS A HIGH VOLTAGE COMPARED TO 3.9 VOLTS WHICH IS WHAT THEY NORMALLY USE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS A FALL. IT WAS NOTED THAT IMPEDANCE MEASUREMENTS WERE ¿OVER 1300 OHMS.¿ IT WAS NOTED THAT IT WAS UNKNOWN IF THE ISSUE WAS DUE TO THE STIMULATOR OR DUE TO THE LEAD AND EXTENSION. IT WAS NOTED REPROGRAMMING WAS DONE ON (B)(6) 2013. IT WAS NOTED THAT A REVISION OR REPLACEMENT WOULD OCCUR. IT WAS FURTHER NOTED THAT THE PROCEDURE HAD NOT BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148202 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention