BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3033645 · Received April 3, 2013

    Report

    Report Number
    3004209178-2013-04575
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 18, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3888-56, LOT# V543664, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V541579, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (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 THE PATIENT FELL ON (B)(6) 2012 OR (B)(6) 2012 AND "PULLED ONE OF THE WIRES LOOSE." IN (B)(6) 2012, THE PATIENT HAD THE LEADS AND IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) NOTED THAT THE PATIENT MET WITH THE MANUFACTURER¿S REPRESENTATIVE AT THE CLINIC ON (B)(6) 2012 WHERE IT WAS CONFIRMED THE FALL OCCURRED OVER MEMORIAL DAY WEEKEND. IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD NOT WORKED SINCE. EVALUATION SHOWED THAT THE LEAD WAS FRACTURED BY THE FALL. THE PATIENT WAS ON MEDICATION (NORCO 10/325 10/DAY) WHICH WAS NOT HELPING THEIR PAIN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT EXPERIENCED A "LEAD BREAK IN (B)(6) 2012". IT WAS FURTHER STATED THE PATIENT'S PHYSICIAN "PUT A NEW UNIT IN TO RESOLVE" THE LEAD BREAK ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136106 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