BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3327785 · Received September 5, 2013

    Report

    Report Number
    3004209178-2013-15722
    Event Type
    Injury
    Date Received
    September 5, 2013
    Report Date
    August 12, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37746 LOT# SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 39286-65 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS DUE TO THE LEAD. IT WAS NOTED THAT THE LEAD WAS NOT IN THE RIGHT PLACE AND THAT IT HAD MIGRATED. IT WAS NOTED THAT THE ISSUE WAS DUE TO THE LEAD AND THAT THE ISSUE WAS DISLODGEMENT AND OR MIGRATION. IT WAS NOTED THAT A REVISION ON THE LEAD HAD OCCURRED. IT WAS NOTED THAT AN X-RAY WAS PERFORMED AND THE RESULTS INCLUDED "MIGRATION." IT WAS NOTED THAT THE PATIENT OUTCOME WAS NO INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD GOOD PAIN RELIEF WITH STIM TRIAL USING PERC LEADS. THE PATIENT HAD PERC LEADS PLACED IN (B)(6) 2013 FOR PERMANENT IMPLANT BUT ONLY GOT STOMACH STIM DESPITE ANY REPROGRAMMING. THE PATIENT WAS HAVING ANTERIOR STIM IN THE TORSO. THE PATIENT RECENTLY HAD SURGICAL LEAD PLACED (B)(6) AND THE MANUFACTURER'S REPRESENTATIVE WENT TO PROGRAM THE PATIENT YESTERDAY ((B)(6) 2013) (THE REPRESENTATIVE WAS INITIALLY TOLD THIS WAS AN INITIAL PROGRAMMING, BUT IT WAS ACTUALLY A PROGRAMMING POST-LEAD REVISION). DURING PROGRAMMING ATTEMPTS YESTERDAY, THE PATIENT STILL WAS ONLY GETTING STOMACH STIM. TARGET WAS LOW BACK AND LEGS. ADDITIONAL INFORMATION RECEIVED ON 2013 (B)(6) NOTED THAT THE PATIENT WAS REFERRED FOR X-RAYS, RESULTS UNKNOWN. THE PATIENT WAS SENT FOR X-RAYS ON DAY FOLLOWING THE EVENT. REPROGRAMMING WAS ATTEMPTED FOR OVER AN HOUR WITH NO IMPROVEMENT. IMPEDANCE RESULTS RANGED FROM 900-1003 ON ALL CONTACTS. NO MALFUNCTIONS OR DEVICE ISSUES WERE SUSPECTED. THIS REPORTER HAD NOT RECEIVED ANY UPDATES ON THE PATIENT'S CONDITION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440550 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention