BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1991998 · Received February 4, 2011

    Report

    Report Number
    3004209178-2011-00895
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 20, 2010
    Report Date
    January 20, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD HER RECHARGEABLE IMPLANTABLE NEUROSTIMULATOR REPLACED ASSOCIATED WITH FOOT SWELLING DURING RECHARGING (REFERENCE MFG. REPORT #3004209178201100893). AFTER REPLACEMENT, THE PT DID NOT FEEL STIMULATION IN HER FOOT, THE TARGET AREA. INSTEAD IT WAS FELT IN HER PELVIC AREA. THE PT SPENT ABOUT 1 HOUR WITH THE FIELD REP. IT WAS DETERMINED THAT ONLY 2 ELECTRODES WERE VIABLE. THE HCP TOOK 5 DIFFERENT X-RAYS AND COMPARED THEM TO ORIGINAL FILMS. THE LEAD WAS EXACTLY WHERE IT WAS SUPPOSED TO BE. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR LEAD: MODEL 39286-65, LOT# V447163033| IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE141764N| EXPLANTED: