BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2951392 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01521
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    January 22, 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

    CONCOMITANT PRODUCTS: PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003,EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3998, LOT# LB2950, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A 'LOW' BATTERY AND FELT IRRITATION AT THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET. THE INS HAD BEEN IMPLANTED 'FOR A FEW YEARS AGO.' IT WAS STATED THAT THE PHYSICIAN PLANNED TO DO AN INS REVISION/REPLACEMENT AND PUT A NEW INS IN THE ABDOMEN INSTEAD OF THE 'FLANK' POSITION. FURTHER INFORMATION HAS BEEN REQUESTED. IF MORE INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. REFER TO MANUFACTURER REPORT #3004209178-2013-01356 FOR INFORMATION ON A RELATED EVENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT ALL DIAGNOSTIC CHECKS WERE GOOD, EXCEPT THAT THE BATTERY NEEDED REPLACEMENT, WHICH WAS GOOD. FOLLOWING THE REPLACEMENT THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57555 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