BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3875313 · Received June 16, 2014

    Report

    Report Number
    3004209178-2014-11649
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Report Date
    May 27, 2014
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 977A160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WANTED THEIR SCS REMOVED ALTHOUGH IT HELPS HER WITH HER PAIN. THE PATIENT STATED THAT THE PATIENT NEVER TURNS IT OFF AND THAT THE GENERATOR SITE WAS TOO ¿SORE.¿ THE SORENESS WAS AT THE DEVICE POCKET. THERE WAS NO ALLEGED PRODUCT ISSUE OR ACTION REQUIRED AS A RESULT OF THE EVENT. IT WAS NOTED THE PATIENT HAD A MEDICAL HISTORY OF PSYCHIATRIC ILLNESS REQUIRING HOSPITALIZATION AND MEDICATIONS. THE PATIENT¿S STATUS WAS NOTED TO BE ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT CALLED THE PHYSICIAN¿S OFFICE STATING THAT SHE WANTED THE PHYSICIAN TO REMOVE THE STIMULATOR. WHEN THE OFFICE STAFF RETURNED THE CALL, THE PATIENT SAID SHE ¿JUST WANTED IT OUT.¿ THE PATIENT WAS OFFERED AN APPOINTMENT TO COME IN AND DISCUSS WITH THE PHYSICIAN, BUT THE PATIENT REFUSED THE APPOINTMENT AND WANTED THE OFFICE TO SCHEDULE HER FOR SURGERY. NO TROUBLESHOOTING HAD BEEN PERFORMED. NO DATE HAD BEEN SCHEDULED FOR AN EXPLANT, AS THE PHYSICIAN WILL NOT SCHEDULE AN EXPLANT WITHOUT AN OFFICE VISIT TO DISCUSS THE PATIENT¿S SITUATION AND EVALUATE HER. SITUATION AND EVALUATE HER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WANTED HER IMPLANTABLE NEUROSTIMULATOR (INS) TO BE TAKEN OUT. IT WAS STATED THAT THE PATIENT WAS IN SO MUCH PAIN IT FELT LIKE IT WAS ¿LAYING ON A NERVE.¿ IT WAS STATED THAT THE PATIENT HAD NOT BEEN ABLE TO GET UP SINCE THE THURSDAY PRIOR TO THE DATE OF THIS REPORT. IT WAS STATED THAT THE PATIENT HAD SEEN HER HEALTHCARE PROVIDER (HCP) IN EACH OF THE TWO PREVIOUS MONTHS AND HAD MENTIONED THAT SHE WANTED THE INS TO BE TAKEN OUT. IT WAS NOTED THAT THE FIRST TIME THE PATIENT MET WITH HER HCP AND MENTIONED THAT SHE WANTED THE INS REMOVED, HER HCP CHANGED HER PAIN PILL. IT WAS NOTED THAT THE PATIENT HAD CALLED HER HCP AND LEFT A MESSAGE STATING THAT ¿[THE PATIENT¿S] GRANDSON WANTS TO TALK TO THEM AND [THE PATIENT] WANTS TO HAVE THE INS REMOVED THE WEEK OF (B)(6) BUT NOT SURE HOW THEY DO THAT.¿ IT WAS STATED THAT THE INS HAD HELPED THE PATIENT FROM (B)(6) TO (B)(6) OF 2013. IT WAS STATED THAT IT FELT AS IF THE INS HAD ¿MOVED OR SOMETHING.¿ IT WAS NOTED THAT THE PATIENT HAD NOT HAD ANY FALLS OR TRAUMA. IT WAS NOTED THAT THE PATIENT HAD TO TAKE PILLS TO SLEEP AT NIGHT. IT WAS STATED THAT THE PATIENT ¿NEVER NEVER SLEEP¿ AND IT WOULD BURN AND WAS UP IN HER RIBS. IT WAS STATED THAT 2 WEEKS AGO, THE PATIENT¿S HCP HAD MOVED ¿IT¿ UP TO WHERE HER RIBS WERE HURTING SO BAD, BUT IT DIDN¿T SEEM TO HELP AND INSTEAD SEEMED TO MAKE IT WORSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352708 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR