BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2842764 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10664
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 25, 2012
    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

    PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) (SERIAL # (B)(4)) FOUND THAT THAT BATTERY WAS AT NORMAL END OF LIFE. THE TELEMETRY AND OUTPUT WERE OKAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD 'SEVERAL FALLS LATELY' AND 'UNCOMFORTABLE' STIMULATION. THE PATIENT REPORTEDLY FELL AND WAS 'BURIED UNDER A BUNCH OF FURNITURE FOR A WHILE.' IT WAS STATED THAT THE PATIENT FELL '4-6 MONTHS AGO' WHERE SHE 'TUMBLED DOWN AN EMBANKMENT INTO A CREEK.' IT WAS NOTED THAT THE PATIENT HAD PROBLEMS WITH FALLS SINCE PRE-IMPLANT. IT WAS STATED THAT THE PATIENT PROGRAMMER DID NOT DO WHAT THE PATIENT 'WANTED IT TO,' AND DID NOT GO UP 'AT ALL FOR A WHILE THEN IT WENT UP TOO MUCH AND GOT UNCOMFORTABLE.' IT WAS NOTED THAT THERE COULD HAVE BEEN A DEAD BATTERY IN THE PATIENT PROGRAMMER AND THAT THE PATIENT 'DID NOT THINK THE DEVICE WAS WORKING PROPERLY.' THE PATIENT REPORTEDLY FELT 'WEAK AND DIZZY ALL THE TIME,' AND THOUGHT SHE WAS ON 'TOO MANY' MEDICATIONS. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED ELECTIVE REPLACEMENT INDICATOR (ERI). IT WAS STATED THAT THE PATIENT PUT NEW BATTERIES INTO HER PROGRAMMER AND WAS ABLE TO ADJUST STIMULATION. IT WAS NOTED THAT THE PATIENT WAS SCHEDULED FOR A DOCTOR APPOINTMENT ON (B)(6) 2012. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD BEEN SEEN BY HER HEALTHCARE PROFESSIONAL (HCP). ELECTIVE REPLACEMENT INDICATOR (ERI) WAS VERIFIED. THE NEUROSTIMULATOR WAS REPLACED AND THERAPEUTIC STIMULATION WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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