BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 10102985 · Received May 29, 2020

    Report

    Report Number
    3004209178-2020-09404
    Event Type
    Malfunction
    Date Received
    May 29, 2020
    Date of Event
    February 22, 2020
    Report Date
    May 29, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A260, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2019, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2019, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ON (B)(6) 2020, INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) CONCERNING PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED PATIENT FEELS SWELLING AROUND INS POCKET SITE, MORE WHEN STIMULATION IS ON. REPORTS WHEN STIMULATION IS OFF SWELLING IS THERE BUT LESS. CALLER REPORTS PHYSICIAN ASPIRATED THE INS POCKET SITE AND THERE WAS NOTHING FROM THE ASPIRATION. CALLER DOES NOT KNOW IF THE STIMULATION WAS ON DURING THE ASPIRATION. CALLER REPORTS PHYSICIAN PALPATED THE INS AND FELT THE INS WAS IMPLANTED IN GOOD LOCATION, FLAT. CALLER REPORTS PATIENT INDICATED BRUISING AT INS TISSUE SITE. REPORTS PHYSICIAN DOES NOT THINK INS IS INFECTED, NO REDNESS, NO SHOCKING. CALLER REPORTS PATIENT INDICATED PAIN AROUND THE INS SITE. CALLER REPORTS NO FALL OR TRAUMA. CALLER REPORTS INTERROGATION OF THE DEVICE ALL WITHIN NORMAL LIMITS, IMPEDANCE, CONNECTION GOOD. REVIEWED NO ALLERGY TEST KIT AVAILABLE. LEAD AND IMPLANT MANUALS WERE EMAIL TO MANUFACTURER REPRESENTATIVE (REP). NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ON (B)(6) 2020, ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) REPORTING THE CAUSE OF THE PAIN AND SWELLING AT THE INS SITE WAS UNKNOWN. IT WAS REPORTED THAT ACTIONS TAKEN TO ADDRESS THE PAIN AND SWELLING AT THE INS SITE WAS THE PATIENT¿S DOCTOR PREVIOUSLY DID A NEEDLE ASPIRATION, BUT NOTHING WAS ABNORMAL. IT WAS REPORTED THAT THE SYMPTOMS HAVE NOT RESOLVED, THE PATIENT STILL COMPLAINS OF BURNING/SWELLING IN THE POCKET WITH THE STIMULATOR ON. IT WAS REPORTED THAT ALL IMPEDANCES WERE IN RANGE AND THE HEADER CONNECTION WAS ALL GREEN. IT WAS INDICATED THAT THE PROVIDED INFORMATION HAD BEEN CONFIRMED WITH THE PHYSICIAN. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566610 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR