BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3033634 · Received April 3, 2013

    Report

    Report Number
    3004209178-2013-04569
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 20, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3777-45 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3777-45 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37743 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE POCKET SITE AND STATED THAT IT CAUGHT WHEN SHE MOVED. THE PLAN WAS TO SCHEDULE THE PATIENT FOR A POCKET REVISION AFTER CARDIAC CLEARANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136309 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