BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3960776 · Received July 28, 2014

    Report

    Report Number
    3004209178-2014-13575
    Event Type
    Injury
    Date Received
    July 28, 2014
    Report Date
    July 1, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL# (B)(4) IMPLANTED: 2012 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37744, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID NEU_TLOCK_ANCHOR, LOT# UNKNOWN, EXPLANTED: 2014 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID NEU_TLOCK_ANCHOR, LOT# UNKNOWN, EXPLANTED: 2014 (B)(6); PRODUCT TYPE ACCESSORY. (B)(4). ANALYSIS OF THE LEAD MODEL 39565-65, SERIAL # (B)(4) SHOWED NO SIGNIFICANT ANOMALIES AND HAD ACCEPTABLE CONTINUITY WITH NO SHORTS SEEN BETWEEN CIRCUITS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD COMPONENT OF THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD MIGRATED TO THE LEFT AND WRAPPED AROUND THE LEFT SIDE OF THE SPINAL CORD. THE MIGRATED LEAD LED TO IRRITATION OF THE NERVE WHICH CAUSED LEFT RIB PAIN AND PAIN AT THE LEAD LOCATION EVEN WHEN THE INS WAS OFF. DIAGNOSTICS AND TROUBLESHOOTING INCLUDED X-RAYS, IMPEDANCE TESTING, AND REPROGRAMMING. THE DEVICE SYSTEM WAS THEN EXPLANTED AND THE PRODUCT ISSUE WAS CONSIDERED RESOLVED. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS NOTED AS ¿ALIVE NO INJURY¿. FOLLOW UP INFORMATION RECEIVED THE NEXT DAY CONFIRMED THAT THE DEVICE SYSTEM WAS REMOVED AND WAS NOT REPLACED. FURTHER FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2014 REPORTED THAT THE PATIENT WAS RECOVERING WELL FROM THE PROCEDURE. IT WAS NOTED THAT THE RIB PAIN THEY WERE HAVING WAS ATTRIBUTED TO THE LEAD MIGRATION AND HAD LESSENED SOME, BUT HAD NOT COMPLETELY RESOLVED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. SEE ALSO MANUFACTURER¿S REPORT # 3004209178-2012-06326 FOR THE PATIENT¿S PREVIOUS LEAD MIGRATION ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438184 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention