BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2944131 · Received February 5, 2013

    Report

    Report Number
    3004209178-2013-01312
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Report Date
    January 16, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3888-33, LOT# V004658, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-33, LOT# V01 1019, PRODUCT TYPE: LEAD. PRODUCT ID: 377645, LOT# V013484, PRODUCT TYPE: LEAD. PRODUCT ID: 3776-45, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PRODUCT ID: 3708260, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708120, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SHOCKING OR JOLTING SENSATION MAINLY WHEN A PATIENT WAS TOUCHING OBJECTS OCCURRED. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. THEY HAD BEEN OCCURRING FOR THE LAST MONTH. THE SYMPTOMS WERE ACUTE PAIN AND SORENESS AT IMPLANTABLE NEUROSTIMULATOR (INS) SITE. IT WAS MENTIONED THAT IT FELT LIKE IT WAS RUBBING INSIDE. IT WAS STATED THAT THE SYMPTOMS SHE WAS HAVING WERE WHAT THE PATIENT WOULD DESCRIBE AS "INFECTION" ALTHOUGH AREA WAS NOT RED, WARM TO THE TOUCH OR SWOLLEN AT LEAST NOT ON THE DAY OF THE REPORT. SOME DAYS IT SEEMED MORE IRRITATED. IT WAS REPORTED THAT WHEN SHE BENT OVER, THE INS "POPPED OUT OR STUCK OUT MORE THAN USUAL." IT WAS SAID THAT EVEN WITHOUT BENDING OVER IT WAS MORE PROMINENT. THE PATIENT'S STATUS WAS DESCRIBED AS FAIR. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47878 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