BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4220997 · Received November 3, 2014

    Report

    Report Number
    3004209178-2014-20850
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 7, 2014
    Report Date
    April 16, 2018
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 977A260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 977A260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE PATIENT WAS IN THE HOSPITAL AFTER HAVING THE DEVICE IMPLANTED, HE WAS IN TOO MUCH POST-SURGERY PAIN TO USE THE DEVICE. THE PATIENT HAD STARTED FEELING SHOCKS AT THE INCISION SITE ON THE DAY THAT HE HAD LEFT THE HOSPITAL AND HAD TURNED THE DEVICE ON, WHICH WAS NOTED TO HAVE BEEN (B)(6) 2014. THE INCISION AREA WAS NOTED TO HAVE HURT. NO INTERVENTIONS OR OUTCOME WERE 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

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL PAIN AND OTHER CHRONIC/INTRACTABLE PAIN (TRUNK/LIMBS). IT WAS REPORTED THAT WHEN THE PATIENT INITIALLY GOT THE STIMULATOR, HE HAD A 45-MINUTE PROGRAMMING SESSION. THEY ONLY DID A 45-MINUTE SESSION, BECAUSE THE PATIENT WAS TIRED AND HURTING FROM THE IMPLANT SURGERY. HE STILL HAD STITCHES, AND THE STIMULATOR HAD BEEN SHOCKING HIM AT THE INCISION AREA WHEN THEY WERE PROGRAMMING. THIS PREVIOUS SHOCKING AT THE INCISION AREA HAD RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703032 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00034 YR