ACTIVA
Report
- Report Number
- 3004209178-2014-10087
- Event Type
- Injury
- Date Received
- June 4, 2014
- Report Date
- May 16, 2014
- 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
- WV, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V103455, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID 3387S-40, LOT# V113842, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID 37612, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3387S-40, LOT# V113842, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).
CONCOMITANT: PRODUCT ID 3387S-40, LOT# V103455, IMPLANTED: 2008-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), PRODUCT TYPE EXTENSION. PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 37651, SERIAL# (B)(4). PRODUCT TYPE RECHARGER. (B)(4).
(B)(4).
IT WAS LATER REPORTED THAT THE PATIENT HAD HAD AN IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT WITH CONNECTION ISSUE WITH INS. THE PATIENT HAD HAD A SECOND SURGERY BECAUSE OF AN ISSUE WITH A BAD CONNECTION. THE PATIENT HAD GONE IN TO SEE IF THAT WAS THE CASE AND THEY HAD FOUND IT. THE LEAD WAS REPLACED BUT NOT THE INS.
IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE HEALTHCARE PROFESSIONAL¿S OFFICE ON (B)(6) 2014 DUE TO HIGH IMPEDANCE. IT WAS NO TED THAT ON THE RIGHT ALL WERE HIGH AND RANGING FROM 3603, 4003, AND 5025. IT WAS NOTED THAT THE PATIENT¿S THERAPY IMPEDANCE WAS 3267 AND THERAPY WAS BEING AFFECTED. THERE WERE NO RECENT FALLS OR TRAUMAS. THE PATIENT¿S SETTINGS WERE 3.8V, 180 MICROSEC, 180HZ. LEFT IMPEDANCES WERE ALL WITHIN NORMAL LIMITS AND PATIENT SETTINGS WERE 2.7, 90 MICROSEC AND 150HZ. THE PATIENT WAS BEING SENT FOR X-RAYS. ADDITIONAL INFORMATION RECEIVED REPORTED PATIENT HAD TREMOR AND STIFFNESS RETURN. NO FURTHER TROUBLESHOOTING HAD BEEN PERFORMED. X-RAY RESULTS WAS UNKNOWN.
ADDITIONAL INFORMATION RECEIVED REPORTED A REVISION HAD NOT BEEN SCHEDULED OR PERFORMED. THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY. IT WAS NOTED THAT THE PATIENT WAS SEEN ON (B)(6) 2014 BY THE HEALTHCARE PROFESSIONAL AND THE PATIENT WAS GOING TO BE SENT FOR A COMPUTERIZED TOMOGRAPHY (CT) SCAN. IT WAS LATER REPORTED THAT THERE WERE ELEVATED IMPEDANCES WITH BILATERAL DEVICES THAT THE PATIENT HAD IMPLANTED. THE LEFT PROGRAMMING WAS C+1-3- AND IMPEDANCES FOR THE LEFT WERE C0-2865, C1 C2 C3 LESS THAN 2000, 01-2202, 02-3459, 03-2756. IMPEDANCES FOR BOTH DEVICES WERE NORMAL IN (B)(6) 2014. IN (B)(6) 2014 HIGH IMPEDANCES WERE FIRST NOTICED ON THE RIGHT DEVICE AND HAD BEEN NORMAL ON THE LEFT DEVICE, C0 WAS LESS THAN 2000 AT THAT TIME. THE PATIENT WAS SEEN 2-3 WEEKS PRIOR TO (B)(6) 2014 AND IT WAS NOTICED AT THAT TIME THAT IMPEDANCES WERE ELEVATED ON BOTH SIDES. A COMPUTERIZED TOMOGRAPHY (CT)SCAN WAS DONE OF THE RIGHT SIDE IN ORDER TO CHECK FOR POSITIONING AND LOCATION OF COMPONENTS. IT WAS NOTED THAT IT WAS HARD TO TELL WHICH SIDE WAS WORSE AT THAT VISIT BUT THE PATIENTBROTHER HAD THOUGHT THE PATIENT WAS WORSE ON THE LEFT SIDE. IT WAS NOTED THAT THE PATIENT HAD TO SIT ON HIS HANDS TO KEEP THEM STILL. THE PATIENT WAS SEEN THURSDAY PRIOR TO (B)(6) 2014 AND HAD SEEMED WORSE ON THE RIGHT SIDE AT THAT VISIT. IT WAS NOTED THAT THE PATIENT WAS GETTING SOME THERAPY BECAUSE WHEN STIMULATION WAS SHUT OFF THE PATIENT WAS MUCH WORSE. IT WAS NOTED THAT THE PATIENT HAD HAD SOME FALLS BUT NOTHING THAT WAS RECENT AND NOTHING THAT HAD BEEN AROUND THE TIME OF STIMULATION CHANGES. AN X-RAY HAD SHOWN THINNING OF THE LEFT LEAD IN THE NECK REGION. THE PATIENT DID NOT HAVE MEDICATIONS, ONLY DEEP BRAIN STIMULATOR THERAPY. WITH STIMULATION ON THE PATIENT SEEMED TO BE WORSE ON THE RIGHT SIDE. RIGHT SIDE IMPEDANCE WERE C0-4014, C2-3917, C3-4991, 02-4735, 03-5860, 13-4058, 23-2534 AND THE PATIENT WAS PROGRAMMED AT C+2-3-. IT WAS PLANNED TO DO A CT SCAN IN THE NEXT COUPLE OF WEEKS TO COMPARE TO THE OLD CT SCAN AND TO CHECK THE LEAD LOCATION AND THINNING. IT WAS FURTHERNOTED THAT THEY WERE LEANING TOWARD DOING A REVISION BUT NOTHING WAS SCHEDULED.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT A REVISION COULD NOT BE SCHEDULED FOR AT LEAST ONE TO ONE AND HALF MONTHS, SO THEY WERE LOOKING AT REPROGRAMMING THE PATIENT THE DAY AFTER THE REPORT. BASED ON PREVIOUSLY REPORTED IMPEDANCES, POTENTIAL PROGRAMMING COMBINATIONS WERE DISCUSSED. IT WAS NOTED THAT THE "PATIENT WAS COMPLAINING OF SHOCKING TO HIS CHEST OR ARM." THE HEALTHCARE PROVIDER (HCP) WAS SEEING THE PATIENT THE DAY AFTER THE REPORT AND WOULD INVESTIGATE THIS BY PALPATING TO RULE OUT ANY ISSUES AND DETERMINE THE LOCATION. THE PATIENT HAD UPPED HIS MEDICATION AND GIVEN HE HAD A POCKET ADAPTOR; ONCE SURGERY WAS SCHEDULED THEY WOULD PLAN TO LOOK AT THE ADAPTOR AND EXTENSION BY TESTING BOTH DEVICES AND REPLACE THE COMPONENTS AS NEEDED. THE FOLLOWING DAY IT WAS REPORTED THAT THE PATIENT HAD DIMINISHED EFFECT WITH THERAPY. THE PATIENT HAD LESS AND LESS EFFECT FROM THE THERAPY. NEUROLOGY THE PATIENT WAS REPORTEDLY BEING SHOCKED IN THE SCALP AREA, INTO HIS ARMS AND LEGS AND THIS HAD HAPPENED FOUR TIMES, EVEN SINCE BEING IN CLINIC ON THE DAY OF THE REPORT. THE PATIENT NOTED THAT IT SOMETIMES HAPPENED WHEN HE REACHED DOWN TO PICK UP SOMETHING OR PET THE DOG. THE PATIENT WAS LAST REPROGRAMMED ON (B)(6) 2014 AND NO SURGERY HAD BEEN SCHEDULED YET. THE REPORTER NOTED THAT THE SYSTEMS WERE WORKING BECAUSE WHEN THEY WERE TURNED OFF, THE PATIENT'S SYMPTOMS WERE MUCH WORSE. THE PATIENT'S MEDICATION USE WAS STEADY AND NORMAL, BUT PRIOR HAD NOT BEEN DOING A GOOD JOB OF TAKING IT. THE PATIENT HAD NO FALLS AND THE LEFT SIDE OF HIS BODY WAS GETTING WORSE.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD HIGH IMPEDANCES ON BOTH IMPLANTABLE NEUROSTIMULATORS (INS) AND WAS NOT GETTING GOOD THERAPY. THE PATIENT HAD BEEN SEEN ¿ABOUT THREE TIMES¿ IN CLINIC AND THE IMPEDANCES HAVE ALWAYS BEEN HIGH ON THE RIGHT INS. IMAGING WAS PERFORMED AND THERE WAS A POTENTIAL BREAK ON THE LEFT SIDE AT THE ¿BEGINNING OF THE LEFT ELECTRODE IN THE NECK REGION.¿ A LEAD REVISION WAS PLANNED FOR BOTH LEADS, BUT IT WAS NOT YET SCHEDULED. THERE WERE FOUR COMBINATIONS ON THE RIGHT SIDE THAT WERE GREATER THAN 4,000 OHMS AND ONLY TWO ON THE LEFT SIDE. HOWEVER, ONLY ONE LEFT SIDE COMBINATION WAS HIGH THE LAST TIME THE PATIENT WAS SEEN. THE HEALTHCARE PROVIDER (HCP) FIRST SAW THE PATIENT ON (B)(6) 2014 AFTER A HIGH IMPEDANCE REFERRAL. THE PATIENT SEEMED MUCH BETTER AT THE FIRST VISIT AND WAS NOW HAVING WORSE SYMPTOMS. THE PATIENT¿S SYMPTOMS REPORTEDLY ¿COME AND GO¿ AND HE WAS NOT TAKING MEDICATION AS DIRECTED. A CAT SCAN WAS ALSO DONE AND THE PATIENT DID NOT REPORT ANY ABNORMAL STIMULATION SENSATIONS. THE HCP PLANNED TO TEST THE LEAD AND IF THERE WERE NO ISSUES WITH THAT, THEY WOULD PLAN TO REPLACE THE EXTENSION OR ADAPTOR.
THE HEALTHCARE PROVIDER (HCP) REPORTED THAT THE PATIENT HAD A REVISION THE DAY PRIOR TO THE REPORT. A NEW LEAD WAS PLACED ON THE RIGHT SIDE AND A NEW POCKET ADAPTOR ON THE LEFT. THE PATIENT'S RIGHT SIDE WAS DOING GOOD, BUT THERE WAS STILL ONE COMBINATION WITH HIGH IMPEDANCES ON THE LEFT. ON THE MORNING OF THE REPORT THE PATIENT WAS PROGRAMMED AROUND THIS COMBINATION, YET HIS RIGHT LEG HAD SOME MOVEMENT, HIS TOES CURLED, AND HIS RIGHT HAND TREMORS WERE WORSE. WHEN THE HCP DECREASED THE PATIENT TO 0.5 VOLTS HE WAS INITIALLY FINE, BUT "ABOUT ONE OR SO MINUTES LATER" HIS RIGHT FOOT STARTED TO MOVE AND HE HAD MILD HAND TREMOR. DECREASING THE STIMULATION RATE MADE THE PATIENT'S HAND TREMOR WORSE. THE PATIENT WAS BETTER WHEN THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 327093 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00063 YR | Required Intervention |