BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2906887 · Received January 10, 2013

    Report

    Report Number
    3004209178-2013-00403
    Event Type
    Injury
    Date Received
    January 10, 2013
    Report Date
    December 19, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3888-56 LOT# V367300, IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3888-56 LOT# V433259, IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3888-56 LOT# V822731, IMPLANTED: 2011 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3888-45 LOT# V841065, IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37754 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID, 37744 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3708240 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3708220 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3888-56, LOT# V822731, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3888-56, LOT# V433259, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3888-56, LOT# V444661, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3888-45, LOT# V841065, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 37754, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: RECHARGER: PRODUCT ID 37744, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD THEIR ENTIRE SYSTEM REMOVED ON (B)(6)-2012. PRIOR TO REMOVAL IT WAS REPORTED THAT 3 LEADS HAD MIGRATED TO THE BATTERY POCKET, AND THE BATTERY HAD MIGRATED OVER THE PATIENT'S SPINE CAUSING PAIN WHEN PRESSURE WAS APPLIED. REFER TO MANUFACTURER #3004209178-2012-06698.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT X-RAY DIAGNOSTICS HAD BEEN USED TO IDENTIFY THE ISSUE. SEVERITY WAS STATED AS MILD. THERE WAS NO SERIOUS ADVERSE DEVICE EFFECT. TEN DAYS LATER IT WAS REPORTED THAT IT WAS NOT KNOWN WHICH LEADS HAD MIGRATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD INCREASED PAIN AND A LEAD MIGRATION. THE PATIENT REPORTED A LOSS OF "SOME" PAIN RELIEF. IT WAS ALSO NOTED THE LEADS AND EXTENSION WERE EXPLANTED. PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13342 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 00052 YR Required Intervention