BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2211150 · Received August 8, 2011

    Report

    Report Number
    3004209178-2011-06124
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 13, 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
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    COUPLING OR COMMUNICATION ISSUES WERE REPORTED. THE INS SEEMED TILTED. ADD'L INFO RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS POOR COUPLING TO THE INS ATTRIBUTED TO WEIGHT GAIN. IT WAS ASSUMED THE INS WAS TOO DEEP IN THE POCKET WITH THE PT WEIGHT GAIN OF 15 LBS. IMPEDANCE CHECKS WERE DONE (B)(6) 2011 AND #6 & #8 <50 OHMS WERE MEASURED. IMPEDANCE CHECKS ON (B)(6) 2011 INDICATED MEASUREMENTS WERE WITHIN SPECS. AN X-RAY WAS TAKEN ON (B)(6) 2011 AND INDICATED NO ABNORMALITIES WITH THE INS. ADDITIONALLY, IT WAS REPORTED THE LEAD HAD MIGRATED. THE HCP WAS ABLE TO PROGRAM ON (B)(6) 2011 AND (B)(6) 2011 AROUND THE LEAD TO AVOID ABDOMEN STIMULATION AND WAS GETTING GOOD COVERAGE. AN INS SITE REVISION WAS SCHEDULED FOR (B)(6) 2011. THE PT DID NOT REQUIRE HOSPITALIZATION DUE TO THE EVENT AND THERE WAS NO INJURY.

    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 48 YR IMPLANTED:| EXPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA144969N| STIM ACCESSORY: MODEL 37092, LOT# 262060001| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3776, LOT# V547668028| PROGRAMMER: MODEL 37743, LOT# NKE156829N| LEAD: MODEL 3776, LOT# V547668027