ACTIVA
Report
- Report Number
- 9614453-2016-05766
- Event Type
- Malfunction
- Date Received
- September 22, 2016
- Date of Event
- September 1, 2016
- Report Date
- September 29, 2016
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4)
THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 37612, SERIAL # (B)(4), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT PRIOR TO THE IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT PROCEDURE, IMPEDANCES WERE MEASURED TO BE HIGH ON ELECTRODES THAT WERE NOT USED FOR PROGRAMMING THERAPY. A PRINTOUT FROM WHEN THE INS WAS INTERROGATED SHOWED SOME ELECTRODE IMPEDANCES WERE ELEVATED, BUT WITHIN NORMAL RANGES. WHEN THERAPY IMPEDANCES WERE MEASURED DURING PRE-OPERATION, ¿XXX OHMS AND XXX VOLTS¿ WERE MEASURED ON THE LEFT SIDE. THE MANUFACTURING REPRESENTATIVE THOUGHT THIS MEANT THE PATIENT WAS NOT RECEIVING THERAPY. THE MANUFACTURER REPRESENTATIVE WANTED TO KNOW WHY THE PATIENT WAS NOT RECEIVING THERAPY. THE PATIENT HAD BEEN PROGRAMMED TO 4.7 MA AND THE IMPEDANCES AT THAT TIME ALLOWED FOR THAT. AS TIME WHEN ON, THE PATIENT¿S IMPEDANCES MAY HAVE GONE UP REACHING THE 10V LIMIT AND CEASING THERAPY. AFTER THE INS WAS REPLACED, SOME IMPEDANCES WERE MEASURED TO BE OUT OF RANGE ON THE RIGHT AND LEFT SIDES. IMPEDANCES WERE MEASURED TO BE THE FOLLOWING ON THE RIGHT SIDE: C-10 = 2158 AND C-11 WAS 2408 OHMS. IMPEDANCES WERE MEASURED TO BE THE FOLLOWING ON THE LEFT SIDE: C-2 = 2595, C-3 = 2586, AND 2-3 = 4492 OHMS. FOLLOW UP WITH THE MANUFACTURER REPRESENTATIVE INDICATED THAT NO FURTHER TROUBLESHOOTING WAS DONE AND THE PATIENT¿S NEUROLOGIST WAS GOING TO PROGRAM ACCORDINGLY.
A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE PATIENT HAD NO THERAPY ON THEIR LEFT SIDE AND THEY WERE DYSKINETIC ON THE RIGHT SIDE OF THEIR BODY. THE PATIENT HAD ALWAYS BEEN DYSKINETIC ON THE RIGHT SIDE OF THEIR BODY. THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). THE PATIENT WAS ON HIGH SETTINGS. A REVISION WAS DONE TO CHANGE THE INS TO A RECHARGEABLE BATTERY. PRIOR TO THE REVISION, ELECTRODE IMPEDANCES WERE MEASURED TO BE "LOW HIGH" AND THERAPY IMPEDANCES WERE MEASURED TO BE ¿XXX¿ OHMS AND ¿XXX¿ VOLTS. THE ELECTRODES WITH LOW IMPEDANCE WERE NOT BEING USED FOR PROGRAMMING. AFTER THE INS WAS REPLACED, THE NEW INS WAS ATTEMPTED TO BE PROGRAMMED TO THE SAME SETTINGS AS THE PREVIOUS INS. WHEN 4.7 MA, 180 HZ, AND 90 USEC WERE ENTERED, A WARNING SCREEN WAS DISPLAYED STATING THE PROGRAM SETTINGS COULD NOT BE USED. THE INS WAS ABLE TO BE PROGRAMMED USING A LOWER LEVEL OF 4.0 MA. THERAPY IMPEDANCES WERE CHECKED AND MEASURED AT 7V, WHICH THE HCP WAS CONCERNED ABOUT. THE HCP HAD CONCERNS THE PATIENT HAD NOT BEEN RECEIVING THERAPY AND 7V WAS ¿HUGVOLTAGE TO GO ON AT.¿ WHEN THE PATIENT WOKE UP AFTER THE REVISION SURGERY, THEY WERE HIGHLY DYSKINETIC AND HAD FACIAL PULLING ON THE RIGHT SIDE OF THE PATIENT¿S BODY WHICH FELT INCREDIBLY UNCOMFORTABLE. THE PATIENT¿S STIMULATION WAS TURNED DOWN TO 2 MA AND THEY FELT MUCH MORE COMFORTABLE. AFTER 45 MINUTES, THE PATIENT WAS STILL DYSKINETIC, BUT THEY HAD IMPROVED A LOT. STIMULATION WAS TURNED DOWN FURTHER TO 1.8 MA. THE HCP STATED THE LEAD PLACEMENT WAS PERFECT AND THE PATIENT NEVER HAD GOOD RESULT ON THEIR RIGHT SIDE. THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE PATIENT WAS ALIVE WITH NO INJURY AND THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. THE PATIENT¿S INDICATION FOR USE IS PARKINSON¿S DISEASE.
A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE PATIENT HAD NO THERAPY ON THEIR LEFT SIDE AND THEY WERE DYSKINETIC ON THE RIGHT SIDE OF THEIR BODY. THE PATIENT HAD ALWAYS BEEN DYSKINETIC ON THE RIGHT SIDE OF THEIR BODY. THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). THE PATIENT WAS ON HIGH SETTINGS. A REVISION WAS DONE TO CHANGE THE INS TO A RECHARGEABLE BATTERY. PRIOR TO THE REVISION, ELECTRODE IMPEDANCES WERE MEASURED TO BE LOW AND THERAPY IMPEDANCES WERE MEASURED TO BE ¿XXX¿ OHMS AND ¿XXX¿ VOLTS. THE ELECTRODES WITH LOW IMPEDANCE WERE NOT BEING USED FOR PROGRAMMING. AFTER THE INS WAS REPLACED, THE NEW INS WAS ATTEMPTED TO BE PROGRAMMED TO THE SAME SETTINGS AS THE PREVIOUS INS. WHEN 4.7 MA, 180 HZ, AND 90 USEC WERE ENTERED, A WARNING SCREEN WAS DISPLAYED STATING THE PROGRAM SETTINGS COULD NOT BE USED. THE INS WAS ABLE TO BE PROGRAMMED USING A LOWER LEVEL OF 4.0 MA. THERAPY IMPEDANCES WERE CHECKED AND MEASURED AT 7V, WHICH THE HCP WAS CONCERNED ABOUT. THE HCP HAD CONCERNS THE PATIENT HAD NOT BEEN RECEIVING THERAPY AND 7V WAS ¿HUG VOLTAGE TO GO ON AT.¿ WHEN THE PATIENT WOKE UP AFTER THE REVISION SURGERY, THEY WERE HIGHLY DYSKINETIC AND HAD FACIAL PULLING ON THE RIGHT SIDE OF THE PATIENT¿S BODY WHICH FELT INCREDIBLY UNCOMFORTABLE. THE PATIENT¿S STIMULATION WAS TURNED DOWN TO 2 MA AND THEY FELT MUCH MORE COMFORTABLE. AFTER 45 MINUTES, THE PATIENT WAS STILL DYSKINETIC, BUT THEY HAD IMPROVED A LOT. STIMULATION WAS TURNED DOWN FURTHER TO 1.8 MA. THE HCP STATED THE LEAD PLACEMENT WAS PERFECT AND THE PATIENT NEVER HAD GOOD RESULT ON THEIR RIGHT SIDE. THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE PATIENT WAS ALIVE WITH NO INJURY AND THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. THE PATIENT¿S INDICATION FOR USE IS PARKINSON¿S DISEASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 620848 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | IPG MFG SWITZERLAND | 37601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |