BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1924830 · Received December 7, 2010

    Report

    Report Number
    9614453-2010-10276
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    December 2, 2010
    Report Date
    August 29, 2018
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    AS RECEIVED FOR ANALYSIS, THE MOLDED RUBBER OF THE DISTAL END OF THE EXTENSION HAD BEEN CUT IN PIECES. ALL FOUR SETSCREW CONNECTOR BLOCKS HAD BEEN REMOVED FROM THE MOLDED RUBBER. THE IMPRESSIONS IN THE MOLDED RUBBER INDICATED THAT THE DISTAL END OF THE EXTENSION HAD BEEN MANUFACTURED CORRECTLY. NONE OF THE REST OF THE EXTENSION WAS RETURNED. ONLY ONE OF THE FOUR SETSCREWS WAS RETURNED. THIS SETSCREW WAS ABLE TO BE COMPLETELY INSERTED AND REMOVED FROM EACH OF THE CONNECTOR BLOCKS WITHOUT DIFFICULTY. PER THE RETURNED PAPERWORK, THIS DAMAGE WAS DONE AT EXPLANT. THE COMPLAINT OF A TWISTED CONNECTOR BLOCK COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, AFTER LOOSENING ALL 4 SCREWS, THE EXTENSION DID NOT SLIP OF THE LEAD. WHEN INSPECTING THE EXTENSION, IT WAS VISIBLE THAT THE MOST DISTAL SCREW PART WAS IN A 45 DEGREE ANGLE AND WAS BLOCKING THE LEAD FROM SLIPPING OFF. AFTER CUTTING THE EXTENSION CONNECTOR IN PARTS, IT WAS FINALLY POSSIBLE TO SAVE THE LEAD WITHOUT VISUAL DAMAGE. AFTER IMPLANTATION OF THE DEVICES, IMPEDANCE MEASUREMENTS WERE REPORTED AS OKAY. THE PT OUTCOME WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC EUROPE SARL 7427T NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXTENSION: MODEL EXTENSION, LOT# UNK| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT# 0204210333| EXPLANTED:| IMPLANTED: