BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3243382 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12191
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    July 5, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7495-51, SERIAL# (B)(4), EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# VA02HC7, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7495-51, SERIAL# (B)(4), EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# VA02HC7, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS ERODING AT THE POCKET SITE. THE PATIENT WAS SCHEDULED FOR SURGERY ON (B)(6), AND THE DOCTOR WOULD DETERMINE AT THAT TIME IF THE DEVICE COULD BE RELOCATED TO THE ABDOMINAL AREA OR IF IT WOULD BE EXPLANTED. ADDITIONAL INFORMATION RECEIVED REPORTED THE DOCTOR REMOVED THE PATIENT¿S LEFT INS, CUT PART OF THE EXTENSION AND REMOVED. IT WAS NOTED THE POCKET WAS CULTURED AND A STAPH CULTURE WAS TAKEN AT THE CONNECTION SITE. A DRAIN WAS PLACED AT THE POCKET SITE AND THE PATIENT WAS CLOSED. IT WAS NOTED THE PATIENT WOULD BE RE-IMPLANTED AT A LATER DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT BOTH THE INS AND THE EXTENSION WERE EXPLANTED. IT WAS NOTED THAT THE PATIENT WAS RECOVERING AND THAT THE POCKET WAS BELIEVED TO BE INFECTED.

    Description of Event or Problem · 1

    (B)(4: )ADDITIONAL INFORMATION REPORTED BY A HEALTHCARE PROFESSIONAL (HCP) REPORTED THE HCP SAID THE PATIENT'S LAST INFECTION WAS 3-4 YEARS AGO.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THERE WAS AN INFECTION. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED DUE TO INFECTION. THE INS WAS REMOVED 3 MONTHS PRIOR TO THIS REPORT. IT WAS UNCLEAR IF BOTH SIDES WERE AFFECTED. THERE WAS A 3 MONTH HEALING TIME BEFORE IMPLANTING THE LEFT SIDE AND ACTIVATING. IT WAS NOTED THAT THE RIGHT SIDE WAS IMPLANTED BUT AT THE TIME OF THIS REPORT THERE WAS NO LEAD CONNECTED. AN ACTIVA SC WAS IMPLANTED THE WEEK PRIOR TO (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344507 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention