BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3042056 · Received April 9, 2013

    Report

    Report Number
    3004209178-2013-04901
    Event Type
    Injury
    Date Received
    April 9, 2013
    Report Date
    March 20, 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
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LEADS WERE DISLODGED AND MIGRATED FROM THE FALL.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION FROM THE HEALTHCARE PROFESSIONAL CONFIRMED THAT THE CAUSE OF THE EVENT WAS A FALL. REPROGRAMMING WAS PERFORMED WITH THE MANUFACTURER¿S REPRESENTATIVE AT WHICH TIME IT WAS DETERMINED LEAD REVISION WAS NEEDED. IT WAS REPORTED THAT THE LEAD REVISION OCCURRED ON (B)(6) 2013 [NOTE: THE MANUFACTURER¿S DEVICE REGISTRY INDICATED THAT THE LEAD WAS EXPLANTED AND REPLACED ON THAT DATE] WITH THE RESULT THAT THE PATIENT HAD BETTER STIMULATION. PATIENT SYMPTOMS WERE CONFIRMED AS ¿LOST STIMULATION¿. NO HOSPITALIZATION WAS REQUIRED FOR THE EVENT. THE PATIENT OUTCOME WAS REPORTED AS NO INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELL ON THEIR RIGHT SIDE, WHERE THE STIMULATOR IS IMPLANTED THE NIGHT PREVIOUS TO REPORT. THE PATIENT WENT TO BED AND FELT "OKAY," BUT HAD STIMULATION IN THE WRONG LOCATION AS OF THE MORNING OF THIS REPORT. IT WAS STATED THE STIMULATION WAS IN THE PATIENT'S KNEES AND BELOW AND NO STIMULATION WAS FELT ABOVE THE KNEES. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146738 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 Required Intervention