BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3222447 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11646
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 20, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DEVICE, SERIAL # (B)(4), FOUND NO SIGNIFICANT ANOMALY. TELEMETRY AND OUTPUT WERE FOUND TO BE OKAY; AND IT WAS NOTED THAT ON THE BASED ON THE INFORMATION RECEIVED, THE DEVICE EXPERIENCED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-60 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3777-60 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG ) WAS DEAD AFTER HEAVY USE. IT WAS NOTED THAT THE DEVICE WAS EXPLANTED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS DEPLETED PREMATURELY AFTER HEAVY USE ¿24/7.¿ IT WAS ADDITIONALLY NOTED THAT THE PATIENT WAS ALIVE WITH NO INJURY OR ADVERSE EVENT AT THE TIME OF THE REPORT AND NO SYMPTOMS OR INJURED WERE RELATED TO THIS EVENT. 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
    322097 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention