BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3001731 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03626
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 19, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377775, LOT # V001276, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 377775, LOT # V001276, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE PROGRAMMER.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED DUE TO DECREASE IN THERAPEUTIC EFFECT AND TWO OVERDISCHARGES. IT WAS STATED THE PATIENT EXPERIENCED PARASTHESIA IN PAIN AREAS. IT WAS STATED THAT PHYSICIAN MODE RECHARGE WAS "INITIATED ON (B)(6) 2012, THE SECOND TIME THE PATIENT HAD LET THE INS GO INTO OVERDISCHARGE MODE." IT WAS NOTED THAT POWER ON RESET WAS RECORDED ON (B)(6) 2012, THE PATIENT HAD A PRE-OPERATIONAL VISIT ON (B)(6) 2013, AND REPLACEMENT SURGERY WAS SCHEDULED FOR (B)(6) 2013. IT WAS STATED ONLY THE INS WAS REPLACED AND ORIGINAL LEADS WERE REUSED. IT WAS ALSO STATED THAT THE PATIENT HAD EFFECTIVE THERAPY WITH THE NEW INS. IT WAS STATED THAT "SCHEDULED THERAPY INITIATED (B)(6) 2013." IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105518 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