BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2770244 · Received October 3, 2012

    Report

    Report Number
    3004209178-2012-08828
    Event Type
    Injury
    Date Received
    October 3, 2012
    Report Date
    September 4, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3998, LOT # V810876, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER. PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER. PRODUCT ID 37712, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION. PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION. PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION. PRODUCT ID 3708120, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION. PRODUCT ID 3708120, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION. PRODUCT ID 3550-39, PRODUCT TYPE ACCESSORY. PRODUCT ID 3550-39, PRODUCT TYPE ACCESSORY. PRODUCT ID 3550-29, PRODUCT TYPE ACCESSORY. ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DEVICE, MODEL 37712, SERIAL NO. (B)(4), FOUND NO ANOMALY. ANALYSIS OF THE EXTENSION 3708140, SERIAL NO. (B)(4), FOUND EXTENSION DISTAL END MOLDED RUBBER CUT; NO SIGNIFICANT ANOMALY. ALTHOUGH THIS EXTENSION WAS RECEIVED NOT COMPLETELY SEATED IN THE OTHER EXTENSION, IT IS UNCLEAR IF THIS WAS CAUSED AT IMPLANT OR EXPLANT BECAUSE THE BOOT HAD ALREADY BEEN REMOVED SO POTENTIALLY THE SETSCREW COULD HAVE BEEN LOOSENED AT EXPLANT. ANALYSIS OF THE EXTENSION 3708140, SERIAL NO. (B)(4), FOUND EXTENSION DISTAL END MOLDED RUBBER CUT; NO SIGNIFICANT ANOMALY. ANALYSIS OF THE EXTENSION 3708220, SERIAL NO. (B)(4), FOUND EXTENSION BODY CUT THROUGH, PRODUCT SEGMENTED; NO SIGNIFICANT ANOMALY. ANALYSIS OF THE ANCHOR 3550-39 FOUND NO ANOMALY. ANALYSIS OF THE ANCHOR 3550-39, FOUND THE ANCHOR CUT SILICONE; NO SIGNIFICANT ANOMALY. ANALYSIS OF THE ACCESSORY KIT 3550-29, FOUND NO ANOMALY. ANALYSIS OF THE LEAD 3778-60, SERIAL NO. (B)(4), FOUND LEAD BODY CUT THROUGH, PRODUCT SEGMENTED; NO SIGNIFICANT ANOMALY. ANALYSIS OF THE LEAD 3778-60, SERIAL NO. (B)(4), FOUND LEAD BODY CUT THROUGH, PRODUCT SEGMENTED; NO SIGNIFICANT ANOMALY. ANALYSIS OF THE EXTENSION 3708120, SERIAL NO. (B)(4), FOUND EXTENSION BODY OUTER INSULATION MELTED (SUSPECTED CAUTERY ARTIFACT); NO SIGNIFICANT ANOMALY. ANALYSIS OF THE EXTENSION 3708120, SERIAL NO. (B)(4), FOUND EXTENSION BODY OUTER INSULATION MELTED (SUSPECTED CAUTERY ARTIFACT); NO SIGNIFICANT ANOMALY. ANALYSIS OF THE DEVICE, MODEL 37702, SERIAL NO. (B)(4), FOUND NO ANOMALY. ANALYSIS OF THE LEAD 3998, SERIAL NO. UNKNOWN, FOUND LEAD BODY OUTER INSULATION MELTED (SUSPECTED CAUTERY ARTIFACT); NO SIGNIFICANT ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT ELECTED TO REMOVE THE IMPLANTABLE NEUROSTIMULATOR DUE TO PAIN. IT WAS NOTED THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED FROM THE EXPLANT WITHOUT SEQUELA. REFER TO MANUFACTURER REPORT # 3004209178-2012-08740.

    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 Required Intervention