BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 4865172 · Received June 24, 2015

    Report

    Report Number
    3004209178-2015-12112
    Event Type
    Injury
    Date Received
    June 24, 2015
    Report Date
    June 2, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA P840001 DEVICE USED WAS NOT INDICATOR FOR URINARY SYMPTOMS BUT FOR PAIN. OFF LABEL USE NOTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 3889-28, LOT # VA0GBSF, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3889-28, LOT # VA0GBSF, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THE PATIENT WAS UNABLE TO URINATE BECAUSE THE LEADS FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM ¿WERE NOT WORKING.¿ ADDITIONAL INFORMATION THEN REPORTED THAT THE INS ¿STOPPED WORKING¿ THE PROGRAMMER SHOWED A FACE OF THE HEALTHCARE PROFESSIONAL (HCP) AND THAT THE INS DID NOT WORK (WAS DEPLETED). THE PATIENT STATED THAT THE INS SHOULD HAVE LASTED 9-10 YEARS BUT DID LAST VERY LONG (LASTED ONLY A YEAR). THE PATIENT HAD TO GO TO THE EMERGENCY ROOM ON (B)(6) 2015 BECAUSE THEY COULD NOT GO THE BATHROOM AND HAD PAIN. THEY HAD A CATHETER PLACED AT THAT TIME. THE PATIENT SAW THE MANUFACTURER¿S REPRESENTATIVE ON (B)(6) 2015 AND THE INS WAS CHECKED. THE REPRESENTATIVE WAS ¿BAFFLED¿ AS WAS THE HCP. THE PATIENT WAS TO HAVE THE INS REPLACED. THE PATIENT STATED THAT THEY ARE A HEART PATIENT AND A DIABETIC AND THAT ANYTIME THEY GO UNDER ¿IT IS HIGH RISK AND POSSIBLE DEATH.¿ THERE WERE NO FURTHER DETAILS, INTERVENTIONS OR AN OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE DEVICE HAD BEEN EXPLANTED AND REPLACED WITH NEW IMPLANTABLE NEUROSTIMULATOR. THE PATIENT INDICATED THAT THAT THE REPRESENTATIVE TOLD THEM THAT IT NEEDED TO BE REPLACED AND LIKELY HAD MALFUNCTIONED BECAUSE IT SHOULD HAVE LASTED FOR 10 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408187 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention