BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2172143 · Received June 15, 2011

    Report

    Report Number
    3004209178-2011-04470
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Report Date
    May 23, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HEALTH CARE PROVIDER BELIEVES A LEAD WAS PUNCTURED DURING A PAIN INJECTION. AN EXPLANT IS SCHEDULED FOR (B)(6) 2011. THE PATIENT'S STATUS WAS UNDETERMINED AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION HAS BEEN 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 LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB006653N| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE114690N| LEAD: MODEL 3998, LOT# V157497| EXPLANTED: