BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 4905321 · Received July 10, 2015

    Report

    Report Number
    3004209178-2015-13121
    Event Type
    Injury
    Date Received
    July 10, 2015
    Report Date
    June 30, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3986A60, LOT # N280989, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3487A-56, LOT # V775091, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3986A60, LOT # N202628, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3487A-56, LOT # V708136, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3986A60, LOT# N280989, IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3487A-56, LOT# V775091, IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3986A60, LOT# N202628, IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3487A-56, LOT# V708136, IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708240, SERIAL# (B)(4) IMPLANTED: 2011 (B)(6); PRODUCT TYPE EXTENSION. UPON RETURN OF THE IMPLANTABLE NEUROSTIMULATOR (INS) ANALYSIS FOUND NO SIGNIFICANT ANOMALIES. THE INS WAS FUNCTIONALLY OKAY WITH INSIGNIFICANT ANOMALIES.

    Additional Manufacturer Narrative · 1

    (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 THE PATIENT HAD A LACK OF EFFICACY. THERAPY WAS SUSPENDED AS AN INTERVENTION AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS LATER REPLACED. IT WAS UNKNOWN IF THE BATTERY DEPLETED NORMALLY. THE EVENT WAS CONSIDERED ONGOING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED NO DIAGNOSTICS OR TROUBLESHOOTING WAS NOTED FOR THE EVENT. THE PATIENT REPORTED A LACK OF EFFICACY. THE SITE REPORTED THAT THE DEVICE WAS INITIALLY EFFECTIVE, BUT LOST ITS EFFICACY, BUT NOT DUE TO DEVICE ISSUE/MALFUNCTION. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT REPLACED. THERAPY WAS SUSPENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450107 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention