BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3971837 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-13794
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 8, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3887-45, LOT# V233316, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3887-45, LOT# V233316, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 355031, LOT# N202671, IMPLANTED: (B)(6) 2009, PRODUCT TYPE SCREENING DEVICE; PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT FELL ABOUT 8 MONTHS AGO AND HAD AN APPOINTMENT 6 MONTHS AGO. IT WAS STATED THAT THE PATIENT HAD FALLEN AND LANDED ON THE BATTERY AND THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) ¿FELT LOOSE.¿ IT WAS STATED THAT ¿THEY LOOKED AT IT AND IT WAS FINE.¿ IT WAS REPORTED THAT THE PATIENT WAS STILL GETTING GOOD COVERAGE. IT WAS STATED THAT THE MANUFACTURER¿S REPRESENTATIVE CHECKED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER¿S REPRESENTATIVE KNEW THE PATIENT AND DID SEE THE PATIENT ABOUT 6 MONTHS AGO. IT WAS STATED THAT ¿ALL SHE WAS TOLD AT THAT TIME WAS TO CHECK THE SYSTEM, NO PATIENT FALL OR LOOSE INS WAS REPORTED TO HER.¿ IT WAS STATED THAT SHE CHECKED THE SYSTEM AND IT WAS WORKING FINE AND SHE DID NOT REPORT THE EVENT. IT WAS STATED THAT SHE ¿MIGHT HAVE DONE MINOR REPROGRAMMING AT THE MOST IN ADDITION TO CHECKING THE SYSTEM.¿ IT WAS NOTED THAT SHE DID NOT SEE ANY EXACT DATES THAT SHE SAW THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446782 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR