BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 7612052 · Received June 18, 2018

    Report

    Report Number
    3004209178-2018-13714
    Event Type
    Injury
    Date Received
    June 18, 2018
    Date of Event
    April 1, 2018
    Report Date
    November 6, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) (NJY324927H) REVEALED NO ANOMALY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THE PATIENT HAD THEIR INS IMPLANTED IN 2016 AND THEY SAW THE LOW INS ICON. THE REP REPORTED THE PATIENT HAD TURNED STIMULATION OFF PRIOR TO A DENTAL SURGERY. THE PATIENT TURNED THE STIMULATION BACK ON AND SAW THE LOW INDICATOR. THE REP STATED THERE WAS A LOW IMPEDANCE FOUND. THE REP REPORTED THE PATIENT WAS SEEN AND THE FOLLOWING IMPEDANCES WERE REPORTED, C0 595 OHMS, C1 1016 OHMS, C2 1016 OHMS, C3 607 OHMS, 01 1049 OHMS, 02 1049 OHMS, 03 70 OHMS, 12 1162 OHMS, 13 1049 OHMS, AND 23 1049 OHMS. THE REP STATED THERE WAS NO INDICATION OF LOW Z FOUND IN THAT PAIR USED FOR PROGRAMMING. THERE WAS NO TRAUMA OR FALLS POSSIBLY RELATED TO THE ISSUE. THE REP REPORTED THE PATIENT WAS SCHEDULED FOR REPLACEMENT ON (B)(6) 2018. THERE WERE NO SYMPTOMS REPORTED. IT WAS NOTED THE PATIENT HAD A DENTAL SURGERY AND LOW INS ICON IN (B)(6). THE REP STATED THE IMPEDANCE ISSUE WAS FOUND ON (B)(6). ADDITIONAL INFORMATION FROM THE MANUFACTURE REPRESENTATIVE (REP) ON (B)(6) REPORTED THE PATIENT CALLED THE HEALTHCARE PROFESSIONAL¿S (HCP) OFFICE AND THE HCP HAD THE REP COME IN TO HELP DETERMINE THE ERROR CODE THE PATIENT RECEIVED BY CHECKING THE BATTERY. THE REP STATED IT COULD NO T BE DETERMINED IF THE DENTAL SURGERY HAD ANY DIRECT EFFECT ON THE DEVICE BECAUSE THE PATIENT HAD NOT USED HER PATIENT PROGRAMMER SINCE THE IMPLANT. THE REP STATED THE PATIENT TURNED OFF THE DEVICE FOR SURGERY AND WHEN SHE WENT TO TURN IT BACK ON AFTER THE SURGERY SHE GOT THE LOW BATTERY IMAGE. THE HCP OFFICE HAD NO FURTHER INFORMATION ON THE TYPE OF DENTAL SURGERY. THE REP STATED THEY WERE NOT SURE WHAT THE CAUSE OF THE LOW IMPEDANCES AND LOW INS ICON WAS. THE REP STATED THE DEVICE WOULD BE RETURNED AFTER IT WAS REPLACED ON (B)(6). THE REP NOTED THE INFORMATION WAS CONFIRMED WITH THE HCP. THERE WERE NO FURTHER COMPLICATIONS THAT HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453219 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention