BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2851054 · Received November 29, 2012

    Report

    Report Number
    3004209178-2012-10926
    Event Type
    Injury
    Date Received
    November 29, 2012
    Report Date
    November 2, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND NO SIGNIFICANT ANOMALY. IT WAS STATED THE INS WAS FUNCTIONALLY OKAY AND THERE WERE INSIGNIFICANT ANOMALIES. ANALYSIS OF THE LEAD (S/N: (B)(4)) FOUND NO SIGNIFICANT ANOMALY. IT WAS STATED THE BODY WAS CUT THROUGH AND THE PRODUCT WAS SEGMENTED. ANALYSIS OF THE LEAD (S/N: (B)(4)) FOUND NO SIGNIFICANT ANOMALY. IT WAS STATED THE BODY WAS CUT THROUGH AND THE PRODUCT WAS SEGMENTED. ANALYSIS OF THE EXTENSION (S/N: (B)(4)) FOUND NO ANOMALY. ANALYSIS OF THE EXTENSION (S/N: (B)(4)) FOUND NO ANOMALY. ANALYSIS OF TITAN ANCHOR 1 FOUND NO ANOMALY. ANALYSIS OF TITAN ANCHOR 2 FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-45 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3778-45 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708120 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3708120 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3550-39 LOT#, PRODUCT TYPE ACCESSORY PRODUCT ID 3550-39 LOT#, PRODUCT TYPE ACCESSORY. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REMOVED ON (B)(6)-2012 "DUE TO MALFUNCTION".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED "SEVERE BURNING" AT THE DEVICE SITE AND AT THE LEAD TIP SITE. THE SYSTEM WAS EXPLANTED, AND THERE WAS NO PATIENT INJURY. IT WAS STATED THAT THE PATIENT RECOVERED WITHOUT SEQUELA. FURTHER INFORMATION HAS BEEN REQUESTED, AND A SUPPLEMENTAL REPORT WILL BE SENT IF NEW INFORMATION BECOMES AVAILABLE.

    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