BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3872343 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-11564
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: IT WAS PREVIOUSLY REPORTED THAT "...THERE WAS NO OTHER INFORMATION TO PROVIDE AS OF 2014-06-13." HOWEVER, IT SHOULD HAVE BEEN REPORTED AS "...THERE WAS NO OTHER INFORMATION TO PROVIDE AS OF 2014-06-09." THE DATE WAS CHANGED FROM 2014-06-13 TO 2014-06-09.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DAY PRIOR TO REPORT THE PATIENT FELL DOWN ON THE ¿RIGHT SIDE WHERE THE IMPLANT WAS.¿ THE SAME DAY, THE PATIENT NOTICED IT WOULD ¿VIBRATE IN THE AREA ABOVE THE STIMULATOR AND WHEN HE TOUCHED IT AND IT WOULD SEEM TO GO OFF WHEN HE TOUCHED THE LEFT SIDE.¿ THE PATIENT MENTIONED THAT THEY HAD THE STIMULATOR FOR ¿ABOUT¿ FOUR WEEKS. THE PATIENT WAS REDIRECTED TO THE HEALTHCARE PROFESSIONAL (HCP). IT WAS LATER REPORTED THAT THE HEALTHCARE PROFESSIONAL (HCP) HAD NOT SEEN THE PATIENT AFTER THE IMPLANT ON (B)(6) 2014. IT WAS ALSO NOTED THAT THE HCP HAD NOT SEEN THE PATIENT SINCE ¿EVENT.¿ IT WAS NOTED THAT IT WAS UNKNOWN IF THE PATIENT REQUIRED HOSPITALIZATION AS A RESULT OF THE EVENT. IT WAS LATER REPORTED THAT THE PATIENT STILL HAD CONCERNS WITH THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THE DOCTOR OR MANUFACTURER REPRESENTATIVE. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT (B)(6) 2014 IT WAS LATER REPORTED BY THE MANUFACTURER REPRESENTATIVE THAT THE PATIENT WAS SCHEDULED TO BE SEEN (B)(6) 2014. IT WAS NOTED THAT THE PATIENT HAD NOT BEEN SEEN AND THAT THERE WAS NO OTHER INFORMATION TO PROVIDE AS OF (B)(6) 2014. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT ACCORDING TO THE PATIENT'S RESPONSE THE DAY AFTER PROGRAMMING ,THE PATIENT WAS DOING WELL AND GETTING GOOD COVERAGE AFTER THE REPROGRAMMING. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE HAD NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349206 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR