ACTIVA
Report
- Report Number
- 3004209178-2018-19555
- Event Type
- Injury
- Date Received
- August 30, 2018
- Date of Event
- May 1, 2018
- Report Date
- April 10, 2019
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- UDI-DI
- 00643169529762
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DURING PROGRAMMING IN CURRENT MODE, THE TABLET PERFORMED AN OOR MEASUREMENT/TEST TO DETERMINE IF THE PROGRAMMED PARAMETERS WOULD BE WITHIN REGULATIONS. IT TESTED ALL ACTIVE PROGRAMS IN THE ACTIVE GROUP. WHEN THE TABLET IS RAMPING UP THE INTENSITY, THIS MEASUREMENT IS RUN AT EACH INCREMENTAL STEP. WHEN A PROGRAMMED VALUE IS FOUND TO BE IN OOR, THE PRESENT AMPLITUDE VALUE WILL CHANGE TO THE VALUE WHERE RAMPING STOPPED. (IE: PROGRAMMED TO 6.5MA BUT RAMPING STOPPED AT 5.5MA, SO YOU WILL SEE PROGRAMMED VALUE CHANGES FROM 6.5MA TO 5.5MA). THE TABLET ALLOWS THE DEVICE TO BE PROGRAMMED TO A HIGHER VALUE, BUT THE ACTUAL OUTPUT WILL STAY AT A VALUE THAT THE SYSTEM CAN DELIVER (BEFORE ENCOUNTERING OOR). TO CLEAR THE OOR ALERT, THE PROGRAMMING WOULD NEED TO BE LOWERED TO A LEVEL PRIOR TO THE OOR TRIGGER POINT. AFTER SPEAKING WITH AN ENGINEER, IT WAS DETERMINED A POTENTIAL REASON WHY THEY SAW THE 'IN/OUT OF OOR' MAY BE DUE TO A FLUCTUATION OF THE IMPEDANCE VALUE OR OTHER INTERNAL INS RAMPING VALUES THAT INVOLVE CAP STACKS BASED ON THE VALUE BEING ASKED OF THE INS. ALSO, WITH AN RC BATTERY, THE BATTERY LEVEL OF THE RC COULD IMPACT WHEN AN OOR VALUE OCCURS (IE: LOW RC BATTERY, OOR MAY TRIGGER AT A LOWER MA LEVEL VS A MORE CHARGED UP INS, OOR MAY TRIGGER AT A HIGHER MA LEVEL). OF COURSE, OOR CONSIDERS MULTIPLE FACETS AT ONCE, NOT JUST ONE. IN SUMMARY, WHAT THEY EXPERIENCED DID NOT APPEAR TO BE OUT OF THE ORDINARY AND WAS FUNCTIONING AS DESIGNED.
PRODUCT ID: 7482A51, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION; PRODUCT ID: 7482A51, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION; PRODUCT ID: 3387S-40, LOT# V091117, PRODUCT TYPE: LEAD; PRODUCT ID: 3387S-40, LOT# V091117, PRODUCT TYPE: LEAD; PRODUCT ID: 37791, LOT# UNKNOWN, PRODUCT TYPE: RECHARGER; PRODUCT ID: 37612, SERIAL# (B)(4), IMPLANTED: (B)(6) 2018, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
SEE REGULATORY REPORT #3004209178-2018-19552 FOR OTHER IMPLANTABLE NEUROSTIMULATOR INVOLVED IN THIS EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THE PATIENT WAS HAVING AN EXTENSION REVISION FOR THE VIM ELECTRODES. THEY CURRENTLY HAD 2 LEADS GOING TO THE GPI AND 2 LEADS GOING TO THE VIM. THE CALLER STATED THE LEADS AND EXTENSIONS GOING TO THE VIM WERE GOING TO BE REMOVED, AND THE RC BATTERY ON THE LEFT WOULD REMAIN IMPLANTED. THE PATIENT NEEDED AN MRI OF THEIR HEAD. THE CALLER WANTED TO KNOW IF THE PATIENT WOULD BE ELIGIBLE FOR THE MRI WITH THE RC BATTERY ON THE LEFT AND THE INTACT SYSTEM ON THE RIGHT SIDE (RC BATTERY WITH 2 LEADS GOING TO GPI). THE CALLER STATED THE REASON FOR THE REVISION WAS THE PATIENT WAS ¿GETTING LIKE INTERMITTENT TINGLING ON THE LEFT SHOULDER.¿ THE CALLER ADDED THAT IMPEDANCES WERE CHECKED HOWEVER AND WERE NORMAL. THE CALLER THEN REPORTED THAT TODAY WHEN THE CONNECTOR THAT WENT FROM THE EXTENSION TO THE LEFT SIDE LEAD WAS OPENED IT WAS NOTICED THAT THE INSULATION HAD BEEN ERODED. ADDITIONAL INFORMATION WAS RECEIVED FROM ANOTHER REP INVOLVED WITH THE CASE AND STATED THAT THE LEADS AND EXTENSIONS WERE REMOVED ON (B)(6) 2019. THEY PLANNED ON REMOVING THE EXTENSIONS AFTER THEY HAD SEEN THAT THE LEAD INSULATION WAS PULLED APART, SO THE 2 EXTENSIONS AND 2 LEADS WERE REMOVED. THEY WERE THE PRODUCTS ASSOCIATED WITH THE LEFT SIDE CHEST AND WERE GOING TO THE VIM ON RIGHT AND LEFT HEMISPHERE. THE PATIENT ALSO WAS IMPLANTED WITH 2 MORE LEADS GOING TO THE GPI 4 YEARS AGO. THE LEFT VIM INS WAS CAPPED, AND THE LEADS REMOVED. OOR WAS REPORTED BUT ALREADY DISCUSSED PREVIOUSLY. THERE WERE NO FURTHER COMPLICATIONS REPORTED.
ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP), VIA A MANUFACTURING REPRESENTATIVE (REP), STATING THE CAUSE OF THE BREAKDOWN OF INSULATION WAS NOT KNOWN, BUT THE HCP ASSUMED IT RESULTED FROM THE LEAD/EXTENSION CONNECTION MIGRATING DOWN INTO THE NECK. THE INSULATION ISSUE WAS RESOLVED BY EXPLANTING THE EXTENSIONS AND LEADS. THE EXPLANTED COMPONENTS WOULD BE REPLACED IN THE FUTURE.
INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE TREATMENT OF PARKINSON¿S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THE PATIENT EXPERIENCED AN ACUTE TREMOR WHEN CHARGING THE INS ON HIS RIGHT SIDE BEGINNING A FEW WEEKS PRIOR AND STATED THAT THIS ISSUE WAS GETTING PROGRESSIVELY WORSE BEGINNING A COUPLE WEEKS PRIOR. THE PATIENT DID NOT EXPERIENCE THIS TREMOR WHEN CHARGING THE INS ON THE LEFT SIDE. THE CALLER CONFIRMED THAT STIMULATION WAS ON WHEN CHARGING THE INS. THE CALLER BELIEVED THIS ISSUE MAY BE RELATED TO THE RECHARGING EQUIPMENT. THE CALLER STATED THE PATIENT HAD 2 SETS OF RECHARGING EQUIPMENT AND USED ONE FOR EACH SIDE BUT NOTED THAT THE SETS MAY GET MIXED UP. THE CALLER ALSO STATED THE PATIENT COULD NOT CHARGE BOTH STIMULATORS AT THE SAME TIME "FROM THE GET-GO" ((B)(6) 2018) BECAUSE IF HE DID, HE GOT REALLY STIFF, HIS LEGS CURLED UP, AND HIS ARMS GOT RIGID. THE CALLER STATED THE PATIENT HAD DYSTONIA AND THIS WAS NOT AS BAD WHEN HE CHARGED ONLY ONE INS AT A TIME. THE CALLER STATED THEN WHEN THE PATIENT CHARGED THE INS, HE PUT A PILLOW BETWEEN HIS LEGS AND SAT IN THE RECLINER. THE CALLER NOTED THE PATIENT HAD 8 COUPLING BARS WHEN THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) ANTENNA WAS RIGHT OVER THE INS. THE CALLER STATED WHEN SHE MOVED THE ANTENNA SLIGHTLY AWAY FROM THE INS (MAYBE 1/4 - 1/2 INCHES) THE INSR STILL DISPLAYED 8 COUPLING BARS, HOWEVER THE TREMOR LESSENED SLIGHTLY. THE CALLER ALSO STATED THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) ANTENNA GOT REALLY HOT WHEN THE PATIENT WAS CHARGING THE INS ON THE RIGHT SIDE BEGINNING (B)(6) 2018. THE CALLER STATED THE REP RECOMMENDED WEARING AN ATHLETIC SHIRT WHEN CHARGING BUT THE CALLER STATED WITHOUT A SHIRT, THE ANTENNA STILL GOT HOT. THE CALLER REITERATED THIS DID NOT HAPPEN WITH THE INS ON THE LEFT SIDE BUT STATED THE PATIENT WAS NOT ALWAYS USING THE SAME ANTENNA WHEN CHARGING THE INS ON THE RIGHT SIDE. THE CALLER ALSO REPORTED THE INS ON THE PATIENT'S RIGHT SIDE DEPLETED QUICKER AND TOOK LONGER TO CHARGE THAN THE INS ON THE LEFT BEGINNING THE END OF (B)(6) 2018. THE CALLER STATED THE INS ON THE RIGHT HAD HIGHER SETTINGS. THE CALLER STATED THE PATIENT CHARGED BOTH THE STIMULATORS EVERY DAY AND BEFORE CHARGING, THE INS ON THE RIGHT WAS AT 50% AND THE INS ON THE LEFT WAS AT 75%. THE CALLER STATED THE INS ON THE RIGHT TOOK AN HOUR TO CHARGE AND THE LEFT TOOK 30 MINUTES TO CHARGE. IT WAS REPORTED THE PATIENT DID NOT SEE THE THERMOMETER ICON WHEN THEY RECHARGED. A REPLACEMENT INSR ANTENNA WAS SENT. THE CALLER WAS REDIRECTED TO FOLLOW UP WITH THE HCP TO ADDRESS THE THERAPY CONCERNS WHEN CHARGING. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP REINTEGRATING INFORMATION REGARDING INCREASED RIGIDITY/TREMOR DURING RECHARGING. THE CALLER STATED THE PATIENT'S WIFE REPORTED WHEN THEY CHARGED BOTH SIDES AT THE SAME TIME, THE PATIENT WAS MORE RIGID. THEY NOW CHARGE JUST ONE AT A TIME AND THE PATIENT STILL EXPERIENCED INCREASED TREMOR WHILE RECHARGING. IT WAS REPORTED THEY HAD 8 COUPLING BARS AND THE PATIENT WAS LAYING DOWN DURING CHARGING. THE PATIENT'S WIFE REPORTED SHE MOVED THE ANTENNA LATERALLY AND THE TREMOR SEEMED TO GET BETTER. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. INFORMATION REGARDING A SUDDEN RETURN OF SYMPTOMS AFTER PROGRAMMING HAS BEEN OMITTED AS IT IS CONTAINED IN PE# (B)(4).
ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURING REPRESENTATIVE (REP), INDICATED THERE WAS NO WAY TO BE CERTAIN WHAT CAUSED THE EXTENSION TO MIGRATE DOWN INTO THE NECK OTHER THAN TO ASSUME IT WAS NOT SECURED WELL ORIGINALLY, AND THAT GRAVITY CAUSED IT TO FELL OVER TIME. IT WAS NOTED AFTER THE LEFT LEADS AND EXTENSIONS WERE REMOVED, THE INS WAS PLUGGED.
ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT THE PATIENT MET WITH THE NEUROLOGIST BUT DIDN¿T FIND OUT ABOUT IF THE EXTENSION WAS OVER THE TOP OF THE IMPLANTABLE NEUROSTIMULATOR (INS). THE CONSUMER CONTINUED TO ALLEGE THAT THE PATIENT WOULD GET HOT AND SWEAT PROFUSELY WHEN RECHARGING THE RIGHT SIDE, BUT IT WAS UNKNOWN IF THIS WAS RELATED TO WHICH RECHARGER WAS BEING USED. ON (B)(6) THE CONSUMER STATED THE ANTENNA WAS HOT AND WHEN THEY TRIED TO REMOVE IT FROM THE PATIENT IT WAS LIKE A MAGNET ON THE SKIN. IT WAS NOTED THE PATIENT WAS VERY THIN AND THEY DIDN¿T FEEL LIKE THE EXTENSION WAS OVER THE TOP OF THE INS. IT WAS SUGGESTED TO PLACE SOMETHING IN BETWEEN THE PATIENT¿S SKIN AND RECHARGER. IT WAS NOTED THE DAY PRIOR THE PATIENT WAS WALKING DOWN THE DRIVEWAY AND THEY HAD A FREEZING EPISODE, BUT THE PATIENT HAD ADVANCED PARKINSON¿S DISEASE WHICH WAS A SYMPTOM OF THAT CONDITION. THE CONSUMER WANTED TO KNOW IF THERE WAS ANYWAY TO DIAGNOSE IF THE DEVICE WAS CHANGING OUTPUT ON ITS¿ OWN OR IF THERE WAS AN INTERMITTENT ISSUE. IT WAS REVIEWED WITH THE CONSUMER THAT THE MANUFACTURER FILE GENERALLY RECORDS BUTTON CHANGES AND THAT INTERMITTENT ISSUES ARE HARD TO DIAGNOSE AS THE IMPEDANCES WOULD NEED TO BE RUN AT THE TIME THAT THE ISSUE WAS OCCURRING. THE PATIENT HAD AN APPOINTMENT WITH THE NEUROLOGIST ON (B)(6),AND THE CONSUMER STATED THEY COULD BE THERE IF NEEDED. IT WAS RECOMMENDED TO THE CONSUMER THAT DURING THAT APPOINTMENT THEY COULD ATTEMPT A PLACEBO TEST WITH THE RECHARGER TO SEE IF THE ISSUE OCCURRED, USE A DISHTOWEL IN BETWEEN THE CHARGER AND SKIN WITH VARYING THICKNESS TO MAINTAIN COUPLING, MARK ONE RE CHARGER RIGHT SIDE ONLY AND BRING THAT RECHARGER TO THE APPOINTMENT TO OBTAIN RECHARGE STATISTICS AND SEE TEMPERATURE OF THE RECHARGER, PERFORM IMAGING SEE IF THE EXTENSION WAS OVER THE BATTERY, AND PERFORM IMPEDANCE TESTS IN DIFFERENT POSITIONS TO TRY TO REPLICATE THE PATIENT¿S SYMPTOMS AND RUN AT THAT TIME. ON (B)(6) THE CONSUMER CALLED BACK AND PROVIDED RECHARGE STATISTICS WHICH CONFIRMED THE TEMPERATURES WERE NORMAL, BUT A FEW SESSIONS HAD POOR COUPLING. THE CONSUMER THEN STATED WHEN THE PATIENT WOULD WAKE UP THEY WOULD PUT THE RECHARGER ON, AND SOMETIMES FALL BACK TO SLEEP. LATER ON THE CONSUMER MENTIONED THE PATIENT¿S ACCOUNTS APPEAR TO BE SOMEWHAT UNRELIABLE AND THE TIME THEY WERE SWEATING, THE PATIENT MAY HAVE JUST BEEN HAVING A FEVER. IN ADDITION, WHEN THE PATIENT CHARGED WITH NO SHIRT AND THEY WERE SWEATING IT MAY HAVE MADE A SUCTION TYPE EFFECT THEY ARE REFERRING TO AS MAGNETIC. THE MANUFACTURER REPRESENTATIVE (REP) MET WITH THE PATIENT ON (B)(6) AND PERFORMED A PLACEBO TEST, AND THE PATIENT WAS FINE WHILE WEARING THE RECHARGER NOT CHARGING AS WELL AS RECHARGING, BUT IT WAS NOTED THE PATIENT WAS WEARING A T-SHIRT AT THIS TIME. THE HEALTHCARE PROVIDER (HCP) ASKED THE REP. IF THERE WAS A CHANGE IN OUTPUT OF THE INS WHILE CHARGING IN CONSTANT CURRENT MODE, AND THEY WERE TOLD NO UNLESS THE EXTENSION WAS OVER THE TOP OF THE INS, THEN IT COULD CAUSE MORE OF AN OVERSTIMULATION SITUATION, BUT NOT UNDERSTIMULATION. ON (B)(6) THE REP. SENT DATA RECORDS THAT WERE GENERATED FROM MEETING WITH THE PATIENT AND NOTED TWO RECHARGER CODES WERE SEEN. IN ADDITION, A VIDEO SHOWED THAT WHEN THE NEUROLOGIST PROGRAMMED THE LEFT LEAD OF THE RIGHT INS AND CREATED A NEW GROUP TO IMPLEMENT A CONSTANT CURRENT SETTING WITH INTERLEAVING, HE KEPT GETTING AN OUT OF REGULATION (OOR) MESSAGE WHICH STARTED AROUND THE 1.5 MILLIAMPS RANGE AND CONTINUED POPPING UP AS THE AMPLITUDE RAMPED UP. THE DEVICE FINALLY REACHED 6.5 MILLIAMPS AND THE ISSUE ACTIVATION GRAPHIC CHANGED FROM ORANGE TO BLUE, BUT THE SYSTEM SUDDENLY JUMPED BACK TO 5.5 MILLIAMPS AND GAVE AN OOR MESSAGE WHICH HAPPENED ON BOTH PROGRAM ONE AND TWO FOR THE LEFT LEAD BUT DIDN¿T HAPPEN ON THE RIGHT LEAD. ALL IMPEDANCE MEASURES WERE IN THE NORMAL RANGE FOR BOTH LEADS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 676690 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37612 | 00643169529762 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |