BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3981807 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-13990
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 11, 2014
    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 8840, SERIAL # UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 37713, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REPORTER WAS IN A CASE WHERE THEY WERE MOVING THE IMPLANTABLE NEUROSTIMULATOR (INS) FROM THE BACK TO THE FRONT OF THE PATIENT¿S BODY. IT WAS NOTED THAT THE INS WAS INTERROGATED BEFORE THE MOVING OF THE INS AND A POWER ON RESET (POR) MESSAGE WAS SEEN, WHICH THE REPORTER WAS CONFUSED AS TO WHY THE BATTERY WOULD SHOW THAT. IT WAS NOTED THAT THE PATIENT HAD NOT USED THE INS IN A YEAR SO THE PATIENT COULD NOT FEEL IT. THE REPORTER NOTED THAT THERE WAS A MEDICAL DECISION TO REPLACE THE BATTERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT WHEN THE PATIENT WAS SEEN AT HIS FOLLOW-UP, THE SYMBOL HAD NOT APPEARED. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS CHECKED WITH THE CLINICIAN PROGRAMMER AND NOTHING CAME UP THEN EITHER. THE REPORTER DID NOT KNOW THE CODE THAT APPEARED AT THE TIME OF THE REPLACEMENT. IT WAS NOTED THAT THE PATIENT WAS DOING WELL WITH GOOD COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457721 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention