BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2681495 · Received August 3, 2012

    Report

    Report Number
    3004209178-2012-06457
    Event Type
    Malfunction
    Date Received
    August 3, 2012
    Report Date
    July 6, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3550-39, LOT# N231804, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE A STIMULATION SENSATION. THE PATIENT STATED THAT THE DEVICE "JUST WASN'T WORKING" AND THAT WHILE HE WAS ABLE TO CONNECT THE PATIENT PROGRAMMER WITH THE IMPLANT, HE COULD NOT FEEL ANYTHING WHEN HE INCREASED THE STIMULATION FROM 1.9 VOLTS TO 9.8 VOLTS. THE PATIENT FURTHER STATED THAT "IT WAS UNBEARABLE WHEN HE INCREASED TO 3 OR 4 VOLTS." IT WAS NOTED THAT THE PATIENT LOST SENSATION AROUND 3 P.M. ON (B)(6) 2012, AND DID NOT HAVE ANY FALLS OR TRAUMA. THE PATIENT STATED THAT HE HAD 2 PROGRAMS AND COULD SET THE PULSE TO SLOW OR FAST. THE PATIENT FURTHER STATED THAT HE COULD NOT FEEL ANYTHING WHEN PROGRAM 1 AND PROGRAM 2 WERE INCREASED TO THE TOP PARAMETER. IT WAS NOTED THAT THE PATIENT'S PAIN HAD RETURNED. THE PATIENT HAD A PHYSICIAN'S APPOINTMENT SCHEDULED FOR (B)(6) 2012. THE PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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