BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3912767 · Received July 3, 2014

    Report

    Report Number
    3004209178-2014-12502
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    November 5, 2018
    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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    (B)(4). 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 PRODUCTS: PRODUCT ID: 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387S-40, LOT# VA0AU0J, IMPLANTED: (B)(6) 2013, EX PRODUCT TYPE: LEAD. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3387S-40, LOT# VA0B9UV, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3387S-40, LOT# VA0AU0J, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3387S-40, LOT# VA0B9UV, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3708660 LOT# SERIAL# (B)(4) IMPLANTED: 2013(B)(6) EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID 3708660 LOT# SERIAL# (B)(4) IMPLANTED: 2013(B)(6) EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID 3708660 LOT# SERIAL#(B)(4) IMPLANTED: 2013(B)(6) EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID 3708660 LOT# SERIAL#(B)(4) IMPLANTED: 2013(B)(6) EXPLANTED: PRODUCT TYPE EXTENSION IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SAW NO DIFFERENCE IN THERAPY WHETHER THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ON OR OFF. IT WAS NOTED THAT THE PATIENT WAS ¿MOSTLY ASYMPTOMATIC¿ EITHER WAY. THE REPORTER STATED THAT THE PATIENT HAD BEGUN TO FEEL SOME PAIN AT THE UPPER RIGHT CORNER OF THE INS SITE AND HAD BEGUN COUGHING WITHIN THE ¿LAST COUPLE DAYS.¿ THE REPORTER STATED THAT THE IMPEDANCES WERE A CONCERN. IT WAS NOTED THAT IMPEDANCE READINGS FROM THE RIGHT INS SHOWED SIX CONTACT PAIRS HAD IMPEDANCES OF GREATER THAN 4000 OHMS. IT WAS NOTED THAT THE PATIENT HAD NOT ENCOUNTERED ANY TRAUMA AND IMAGING HAD REPORTEDLY SHOWED NO CLEAR PROBLEMS IN THE SYSTEM. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE AREA AROUND THE IMPLANT STILL HURT IF YOU TOUCHED IT AND IT HAD BEEN A YEAR AND A HALF SINCE THE DEVICES WERE IMPLANTED. PATIENT INQUIRED IF THIS WAS NORMAL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT. IT WAS REPORTED THAT THE PATIENT WAS STILL EXPERIENCING PAIN AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE SINCE IMPLANT. THE PATIENT STATED THAT THE PAIN MEDICATIONS WORE OFF AND THEY "CANNOT SUSTAIN A STEADY FEELING". THE PATIENT STATED THAT THE "FEELINGS" WERE SPASMS IN THEIR NECK, AND THAT THE WIRES PROTRUDED AND PULLED BETWEEN THEIR NECK AND CHEST CAUSING A TALKING PROBLEM. WHEN THE DEVICE WAS TURNED OFF, THE ISSUE WAS NOT RESOLVED. THE PATIENT HAS ALSO HAD HER PROGRAMMING ADJUSTED WHICH CORRECTED HER WALKING.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT AND THE PATIENT FELT THERAPY WAS NOT REALLY DOING ANYTHING. THE PATIENT HAD NEVER BEEN ABLE TO GET THE DEVICE ADJUSTED TO THE POINT WHERE IT WOULD DO ANYTHING. THE PATIENT WAS STILL EXPERIENCING A LOT OF DYSKINESIA AND DID NOT FEEL THAT SHE WAS GETTING ANY OF THE ADVANTAGE THAT HAD BEEN EXPECTED. THERE WAS NOT A 50% REDUCTION IN SYMPTOMS. IN (B)(6) 2014 THE PATIENT HAD MET WITH A MANUFACTURING REPRESENTATIVE WHO MADE A CHANGE THAT HAD HELPED A LITTLE BIT AND SINCE THEN THE PATIENT HAD NOT HAD AS MUCH DYSKINESIA BUT IT WAS STILL NOT GIVING THE PATIENT THE EFFECTS SHE WANTED. THE PATIENT WAS STILL TAKING THE SAME AMOUNT OF SINEMETS, 6, AS SHE WAS BEFORE THE IMPLANTS. THERE WAS ALSO PAIN WHERE THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS LOCATED AND HAD BEEN PRESENT SINCE IMPLANT. IT HURT TO TOUCH THEM AND IT WAS A LITTLE PUFFY AROUND THE INSS BUT NOT MUCH BUT IT WAS NOT RED AROUND THE INS SITES. PATIENT ALSO EXPERIENCED TROUBLE SLEEPING ON HER STOMACH. PAIN WAS ALSO OCCURRING IN THE PATIENT'S BACK AND NECK BUT THIS PAIN HAD BEEN PRESENT PRIOR TO IMPLANTS, IT WAS NOTED TO BE PARTIALLY BECAUSE OF PARKINSON'S AND ARTHRITIS. IT WAS NOTED THAT THE PAIN IN THE PATIENT'S CHEST FROM THE INSS MADE THE PAIN WORSE. THE PATIENT HAD GONE TO SEE HER HEALTHCARE PROFESSIONAL IN (B)(6) 2014 AND EVERYTHING LOOKED FINE. THE PATIENT HAD FELT SOMETHING SNAP IN HER NECK THE WEEKEND AFTER SURGERY. BOTH OF THE LEADS AND INS'S HAD BEEN IMPLANTED IN THE SAME SURGERY. FOLLOWING THE SNAP THE PATIENT HAD NOTIFIED HER HEALTHCARE PROFESSIONAL AND GONE INTO TO SEE HIM A WEEK OR TWO LATER TO HAVE IT CHECKED. EVERYTHING WAS FINE AT THAT TIME ALSO.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. IT WAS REPORTED THAT THE PATIENT HAD ELECTRICAL SENSATIONS UP THE NECK. THEY STATE THAT THEY HAD A CARDIAC MONITOR PUT ON. PATIENT STATES SHE HAD AN ELECTRICAL SENSATION GO UP HER NECK LAST WEEK AND THEN IT WENT AWAY. PATIENT STATES 3 OF THE LEADS FROM THE MONITOR HAD MOVED CLOSER TOGETHER AND WHEN THE TECH REMOVED THE MONITOR LEADS AND MOVED THEM FARTHER APART THE SENSATION WENT AWAY. PATIENT STATES SHE FELT THIS SENSATION 3-5 TIMES OVER THE LAST FIVE YEARS. THE SENSATION COMES AND GOES. THE PATIENT ALSO REITERATES THE NECK PAIN AND STATES THAT THE REASON SHE IS HAVING CONSTANT SPASMS ARE BECAUSE THE WIRES WERE PLACED TOO CLOSE TO THE SKIN AND THEY STATE IT IS ALSO DUE TO THE PLACEMENT OF THE INS IN THE LOWER RIGHT BREAST AREA. THE INS IMPLANT SITE IS CAUSING PAIN. PATIENT STATES THIS HAS BEEN A NIGHTMARE SINCE IMPLANT. PATIENT SAYS THEY ARE EXTREMELY HAPPY WITH THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389587 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR