ACTIVA
Report
- Report Number
- 3004209178-2012-10004
- Event Type
- Injury
- Date Received
- November 7, 2012
- Report Date
- October 8, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MRU
- PMA / PMN Number
- H020007
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
ANALYSIS OF NEUROSTIMULATOR MODEL 37601 SERIAL # (B)(4) SHOWED NO SIGNIFICANT ANOMALIES AND WAS AT A NORMAL END-OF-LIFE (EOL) STATUS.
PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 64002, LOT# N341532, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ADAPTER; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387S-40, LOT# V047230, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V045101, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).
ADDITIONAL INFORMATION STATED THERE WAS A PRIMARY CELL BATTERY ¿FAILURE.¿ IT WAS REPORTED THE DEVICE HAD DISPLAYED AN EOS MESSAGE ¿A MONTH AFTER IMPLANT.¿ THE BATTERY WAS REPORTED TO HAVE BEEN REPLACED ON (B)(6) 2013. THE PATIENT¿S OUTCOME WAS REPORTED AS ¿ALIVE ¿ NO INJURY/ADVERSE EVENT.¿
IT WAS REPORTED THAT THE PATIENT'S DEVICE DISPLAYED AN ESTIMATED REPLACEMENT INDICATOR (ERI) MESSAGE AND THE OUT OF REGULATION (OOR) MESSAGE. IT WAS NOTED THAT PATIENT HAD 'TAKEN 2 SIGNIFICATION FALLS ON THE SIDE OF THE IMPLANT.' IT WAS NOTED THAT THE PATIENT FELL ON HIS 'POSTERIOR RIGHT SHOULDER AND THE INS WAS LOCATED ON THE ANTERIOR RIGHT SHOULDER.' IT WAS NOTED THAT A LONGEVITY CALCULATION WAS PERFORMED TO ESTIMATE THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY LIFE. IT WAS NOTED THAT WHEN USING 500 OHMS, THE ERI INDICATED 12.49 MONTHS AND THE END OF SERVICE (EOS) INDICATED 15.49 MONTHS. IT WAS FURTHER NOTED THAT WHEN USING 1000 OHMS, THE ERI INDICATED 22.17 MONTHS AND THE EOS INDICATED 2.1 YEARS. IT WAS NOTED THAT THE 'INS BATTERY DEPLETION WAS REPORTED AS PREMATURE.' ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS TOLD BY THE HEALTH CARE PROVIDER (HCP) THAT 'THE INS WAS GIVING AN INCORRECT SIGNAL BECAUSE THEY GOT 2 TO 3 DIFFERENT READINGS ON THE VOLTAGE LEVEL.' IT WAS NOTED THAT THE PATIENT'S DEVICE WAS CHECKED IN (B)(6) 2012 AND THE 'BATTERY VOLTAGE WAS A LITTLE LOWER THAN THE HCP WOULD HAVE LIKED TO SEE.' IT WAS NOTED THAT PATIENT'S VOLTAGE 'HAD DROPPED QUITE A BIT.' ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT 'SEEMED TO BE HAVING A HARDER TIME TALKING.' IT WAS NOTED THAT THE PATIENT WAS 'CONSIDERING TAKING BACLOFEN.' IT WAS NOTED THAT THE PATIENT'S MOTHER CHECKED HIS DEVICE WITH 2 DIFFERENT PATIENT PROGRAMMERS AND SAW THE OOR MESSAGE ON BOTH OF THEM. IT WAS NOTED THAT THE 2ND OOR WAS RESOLVED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PHYSICIAN PERFORMED A THERAPY IMPEDANCE TEST AND ELECTRODE IMPEDANCE TEST. IT WAS NOTED THAT THERE WERE NO OPEN OR SHORT CIRCUITS DETECTED. THE PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S 'BATTERY CASE' MAY HAVE 'COME OPEN' INSIDE OF THE PATIENT AND 'TURNED.' IT WAS STATED THAT THERE WAS A 'HARD METAL PIECE THAT COULD BE FELT UNDER THE BATTERY NEAR THE PATIENT'S ARM.' IT WAS ALSO NOTED THAT A METAL TIN WAS PLACED OVER THE BATTERY AND 'IF THE LID OF THE TIN WAS SHIFTED HE GOT THE SAME SHAPE AS THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS)' AND THAT WAS WHY IT WAS THOUGHT THAT THE INS CASE HAD OPENED. IT WAS NOT CLEAR WHAT THAT STATEMENT MEANT. IT WAS REPORTED THAT THE INS WAS 'SHIFTING UNDER THE PATIENT ARM.' IT WAS STATED THAT THE PATIENT WAS STILL SEEING OUT-OF-REGULATION (OOR) MESSAGE ON THE PROGRAMMER, BUT THE VOLTAGES WERE REPORTED TO BE STEADY. ON (B)(6) 2012 THE INS WAS CHECKED OUT BY A DOCTOR AND THE VOLTAGE WAS 2.63V, ON (B)(6) 2012 IT WAS 2.79V, ON (B)(6) 2012 IT WAS 2.77V, AND ON (B)(6) 2012 IT WAS 2.72V. IT WAS STATED THAT THERE WAS AN ERROR CODE INDICATING THAT THE PATIENT SHOULD CALL THE DOCTOR. IT WAS NOT DETERMINED WHY THE ERROR CODE APPEARED BECAUSE 'THINGS SEEMED TO CHECK OUT FINE.' IT WAS REPORTED THAT THE PATIENT 'SEEMED OK' BUT WAS CONCERNED ABOUT INS POSITION AND CONTINUED OOR READING.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT A PATIENT'S DEVICE WAS AT ERI AND WAS READING 2.69 VOLTS. IT WAS NOTED THAT ERI WAS NOT SUPPOSED TO TRIP UNTIL 2.6 VOLTS. THE ERI WAS FIRST SEEN IN SEPTEMBER OR OCTOBER 2012. THE REPORTER STATED THAT THEY WERE "KIND OF SURPRISED" THAT IT WAS DRAINING SO FAST. IT WAS REPORTED THAT THE PATIENT HAD "VERY REASONABLE" VOLTAGE SETTINGS AND THE PULSE WIDTH WAS "A LITTLE BIT HIGH." THE REPORTER STATED THAT IT WAS HARD TO TELL IF THE PATIENT WAS HAVING THERAPY ISSUES. IT WAS NOTED THAT THERE HADN'T BEEN ANY DRAMATIC CHANGES. IMPEDANCES WERE TESTED AT 1.5 VOLTS AND ALL WERE IN A NORMAL RANGE. IT WAS REPORTED THAT THE PATIENT'S DOCTOR WAS GOING TO MONITOR THE VOLTAGES. IT WAS NOTED THAT THE LONGEVITY ESTIMATE BASED ON THE PATIENT'S PARAMETERS WOULD BE 8.6 MONTHS TO ERI AND 11.64 MONTHS TO END-OF-SERVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
ADDITIONAL INFORMATION RECEIVED ATTRIBUTED THE EVENT TO THE STIMULATOR. BATTERY DEPLETION WAS MARKED AS PREMATURE. HOSPITALIZATION WAS REQUIRED AND THE PATIENT OUTCOME WAS NOTED AS NO INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MRU | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |