BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 8833955 · Received July 26, 2019

    Report

    Report Number
    3004209178-2019-14410
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Date of Event
    July 18, 2019
    Report Date
    July 26, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994761064
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3387S-40, LOT#: V971421, PRODUCT TYPE: LEAD. PRODUCT ID: 37602, SERIAL#: (B)(4), PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 748351, SERIAL#: (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT#: VA0MAMF, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3387S-40, SERIAL/LOT #: (B)(4), UBD: 01-NOV-2014, UDI#: (B)(4); PRODUCT ID: 748351, SERIAL/LOT #: (B)(4), UBD: 04-JAN-2017, UDI#: (B)(4); PRODUCT ID: 3387S-40, SERIAL/LOT #: (B)(4), UBD: 14-MAY-2017, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3387S-40 LOT# V971421 PRODUCT TYPE LEAD PRODUCT ID 37602 (B)(4) PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 748351 (B)(4) PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40 LOT# VA0MAMF SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD CORRECTION FOR PATIENT WEIGHT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR PARKINSON¿S DUAL, MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT HAD A BATTERY CHANGE ON THEIR RIGHT SIDE (B)(6) 2019 AND COMPLAINED OF PAIN, TINGLING, AND STABBING PAIN IN THEIR HEAD POST-SURGERY. THEY RECOMMENDED THE PATIENT TURN OFF THEIR STIMULATION AND PROCEED TO THE ER. THE ISSUE WAS NOT RESOLVED. ADDITIONAL INFORMATION RECEIVED FROM A CONSUMER INDICATED THEY HAD SURGERY YESTERDAY FOR NORMAL BATTERY REPLACEMENT. SINCE THEN, THEY FELT A BIG KNOT ON THE RIGHT SIDE OF THEIR HEAD ABOVE THE EAR. THEY SAID IT HURTS ALL THE TIME, FEELS SORE, AND GIVE THEM A HEADACHE. IT WAS NOTED THIS NEVER HAPPENED BEFORE WITH ANY PREVIOUS STIMULATORS AND THEY THINK THEY MAY HAVE GOTTEN THE WRONG STIMULATOR. THE PATIENT WAS REDIRECTED TO FOLLOW-UP WITH THE HEALTHCARE PROVIDER (HCP) TO CHECK THEY SYMPTOMS AND DEVICE. ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE CAUSE OF THE PAIN/TINGLING POST OP WAS NOT DETERMINED. THE PATIENT PROCEEDED TO GO TO THE ER AND IMPEDANCES WERE CHECKED. THEY ALL CAME BACK NORMAL. THE REP HAD INFORMED THE SURGEON AND PHYSICIAN THAT THE DBS DEVICE CHECKED OUT NORMAL. THE ISSUE WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627701 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602 00613994761064

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR