BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3821824 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-09301
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    December 20, 2011
    Report Date
    May 21, 2014
    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

    SUPPLEMENTAL SUBMITTED FOR ADDITIONAL INFORMATION RECEIVED AND FOR ADDITION OF PATIENT CODING. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD STIMULATION IN THE WRONG LOCATION AND AS A RESULT THE FIRST SET OF LEADS WERE EXPLANTED. **INFORMATION OMITTED PERTAINING TO EVENT (B)(4) ¿ STIM WRONG LOCATION/EXPLANT #2. THESE EVENTS ARE NOT RELATED. IT WAS REPORTED THE PATIENT¿S FIRST SET OF LEADS WERE EXPLANTED ON (B)(6) 2011. INFORMATION OMITTED PERTAINING TO EVENT (B)(4) ¿ STIM WRONG LOCATION/EXPLANT #2. THESE EVENTS ARE NOT RELATED. ADDITIONAL INFORMATION RECEIVED REPORTED THE MANUFACTURER REPRESENTATIVE HAS NO RECOLLECTION OF THE EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT AT A POST-OPERATIVE APPOINTMENT ON (B)(6) 2011 THE PATIENT HAD NO LEFT LEG AND FOOT COVERAGE. IT WAS NOTED THAT THE PATIENT WAS SCHEDULED FOR FOLLOW-UP REPROGRAMMING AND THE PATIENT REPORTED "OK" COVERAGE IN THEIR LEFT LEG AND FOOT AFTER THIS PROGRAMMING SESSION ON (B)(6) 2011 BUT THEN REPORTED ON (B)(6) 2011 THAT IT WAS "NOT COVERING." IT WAS REPORTED IMAGES WERE TAKEN ON (B)(6) 2011, (B)(6) 2011 AND IT WAS DETERMINED THE LEADS HAD NOT MOVED SO THE PATIENT WAS SCHEDULED FOR THE PREVIOUSLY MENTIONED REVISION ON (B)(6) 2011. OF NOTE, IT WAS MENTIONED THE MANUFACTURER REPRESENTATIVE BECAME AWARE OF THE EVENT ON (B)(6) 2011 WHICH WAS UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300292 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention