BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3188286 · Received June 25, 2013

    Report

    Report Number
    3004209178-2013-10854
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    March 1, 2013
    Report Date
    June 4, 2013
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD, PRODUCT ID: 3888-45, LOT# V780541, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-33, LOT# V238362, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V836553, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION, PRODUCT ID: 37754, SERIAL#( B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: NEU_UNKNOWN_PROG, PRODUCT TYPE: PROGRAMMER, PHYSICIAN PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V780541, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD, PRODUCT ID: 3888-33, LOT# V238362, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V836553, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT # V780541, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3888-33, LOT # V238362, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT # V836553, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3708120, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID NEU_UNKNOWN_PROG, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT # V780541, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3888-33, LOT # V238362, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT # V836553, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE CAUSE OF THE EVENT WAS THAT THE PATIENT FELL ON ICE DURING THE WINTER. THE MANUFACTURER'S REPRESENTATIVE DETERMINED THAT 4 OF 8 LEAD NOT ACTIVE. REVISION WAS PLANNED FOR (B)(6) 2013. HOSPITALIZATION WAS NOT REQUIRED. PATIENT OUTCOME WAS NOTED AS NO INJURY. IT WAS LATER REPORTED ON (B)(6) 2013 THAT THE REPORTER HAD QUESTIONS REGARDING HOW TO REORIENT INS AFTER POCKET REVISION. THE PATIENT HAD LEAD IMPEDANCE ISSUES SO A LEAD WAS REPLACED AND AT THE SAME TIME THEY PERFORMED POCKET REVISION BECAUSE THE INS WAS A LITTLE TO PROMINENT. THEY WERE SEEING THE PATIENT FOR THE FIRST TIME TODAY SINCE REVISION. REVISION WAS ON (B)(6) 2013. CALLER STATES POCKET IS DOING WELL NOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT THIS OCCURRED FOLLOWING A FALL. IT WAS NOTED THAT THE PATIENT FELL ON HER BOTTOM IN (B)(6) OF 2013. IT WAS FURTHER NOTED THAT SINCE THAT TIME THE PATIENT¿S PAIN SYMPTOMS HAD STEADILY INCREASED. IT WAS FURTHER NOTED THAT THE PATIENT MET WITH MANUFACTURING REPRESENTATIVE ON THE DAY OF REPORT AND HE INFORMED HER THAT SHE HAD ¿4 BROKEN WIRES.¿ IT WAS NOTED THAT HEALTHCARE PROFESSIONAL (HCP) WOULD BE REVISING THE SYSTEM. IT WAS FURTHER NOTED THAT THE PROCEDURE HAD NOT BEEN SCHEDULED YET.

    Description of Event or Problem · 1

    IT WAS PREVIOUSLY REPORTED THAT THERE WAS LEAD MIGRATION/DISLODGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288125 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention