ACTIVA
Report
- Report Number
- 3004209178-2018-23693
- Event Type
- Malfunction
- Date Received
- October 23, 2018
- Date of Event
- August 1, 2018
- Report Date
- April 1, 2019
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- UDI-DI
- 00613994934611
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HCP WAS UNABLE TO GET THE PATIENT'S IMPLANT TURNED ON. IT WAS STATED THE PATIENT WAS CHARGING AND THE INS SHOWED THE 1ST QUARTILE FULL (25%) CHARGED, AND THE 2ND QUARTILE WAS BEING CHARGED. WHEN USING THE PATIENT PROGRAMMER TO TURN THE INS BACK ON,THE PATIENT PROGRAMMER STATED "LOW" AND WAS UNABLE TO TURN THE INS ON. THE HCP WAS WALKED THROUGH USING THE RECHARGER, AND THE PATIENT SUCCESSFULLY TURNED THE INS BACK ON. FURTHER INFORMATION RECEIVED STATED THAT SINCE THE PATIENT WAS IN A NURSING HOME, IT WAS DIFFICULT TO ENSURE THAT THE IMPLANT STAYED CHARGED. IT WAS NOTED THERE HAD BEEN "LIKE 3 TIMES" WHERE THE IMPLANT DEPLETED TO OFF FROM NOT BEING CHARGED, AND THE PATIENT'S TREMORS CAME BACK. THE ISSUE RESOLVED ONCE THE PATIENT'S IMPLANT WAS CHARGED UP AND TURNED BACK ON. PATIENT AND TECHNICAL SERVICES ALSO REVIEWED THAT THE INS LOW ICON HAD TO BE CLEARED ON THE PATIENT PROGRAMMER FIRST TO BE ABLE TO TURN THE IMPLANT BACK ON WITH THE PATIENT PROGRAMMER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE CALLER SAID THEY WERE GETTING THE REPOSITION ANTENNA SCREEN ON THE RECHARGER. THE CALLER STATED THE INSR WAS 100% CHARGED. THE CALLER REPORTED THE IMPLANT WAS TAKING A LONG TIME TO CHARGE FOR SEVERAL MONTHS. THE CALLER STATED LAST WEEK THEY CHARGED UP THE INS BUT WERE LOSING COUPLING BARS .THE CALLER STATED THEY SPOKE WITH THEIR REP AND THEY TOLD THEM TO CALL PATIENT SERVICES. THERE WERE NO FURTHER COMPLICATIONS REPORTED.
B1: B1 WAS UPDATED TO ADVERSE EVENT AND A PRODUCT PROBLEM. B3: DATE OF EVENT HAS BEEN UPDATED AN IS AN APPROXIMATE. H6: FDP (B)(4) WAS UPDATED TO (B)(4). 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.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) INDICATING THAT THE BATTERY IS NOT CHARGING ABOVE 50% AND REPORTS OF BATTERY GETTING TURNED OFF WHERE THE FAMILY HAS HAD TO TURN THE THERAPY BACK ON. PATIENT IS IN A NURSING FACILITY AND HAS HAD MULTIPLE NURSES CHARGING PATIENT'S DEVICE. PATIENT IS UNABLE TO COMMUNICATE WITH NURSING STAFF. THE PATIENT HAS NOT BEEN RECENTLY REPROGRAMMED OR SWITCHED TO NEW GROUPS. THE PATIENT HAS NOT HAD THE NEED RECENTLY TO INCREASE PARAMETERS. PATIENT HAS NOT HAD ANY PREVIOUS OVERDISCHARGES. NO TRAUMA/FALLS REPORTED. NO RECENT UNRELATED MEDICAL PROCEDURES. NO ACTIVITIES/EMI RELATED TO THIS EVENT. THE REP INTERROGATE THE INS WITH TABLET TODAY. RECHARGING STATISTICS WERE LOCATED AND 2 OUT OF 6 SESSIONS THEY HAD COUPLING OF 7-8 BARS, 2 OUT OF 6 SESSIONS HAD A CHARGE DURATION OF 55-63 MINUTES AND THE REST WERE LESS THAN 27 MINUTES. IT WAS SUGGESTED TO USE ADHESIVE DISCS. IT WAS REVIEWED HOW THE NUMBER OF EFFICIENCY BARS WILL AFFECT RECHARGING TIME AND RECOMMENDED TO CHARGE UP TO 100% TO INCREASE TIME BETWEEN CHARGES. REVIEWED AVERAGE TIME OF 1-2 HOURS TO CHARGE TO FILL INS A QUARTILE. PER STATS IT DIDN'T SEEM THAT THE INS BATTERY WAS CLOSE TO SHUTTING OFF DUE TO LOW BATTERY. TROUBLESHOOTING WAS REPORTED TO RESOLVE THE ISSUE. SYMPTOMS REPORTED INCLUDED THE PATIENT GETTING UNCOMFORTABLE WITH THE HARNESS WHILE RECHARGING.
ADDITIONAL INFORMATION RECEIVED REPORTED THE HEALTHCARE PROFESSIONAL (HCP) WAS CHARGING THE PATIENT'S INS AND GETTING 8 COUPLING BOXES. THE HCP STATED THE 1ST QUARTILE WAS FULL AND THE 2ND QUARTILE WAS BEING CHARGED. IT WAS NOTED THAT THE INS WAS OFF, AND THEY WANTED TO TURN IT ON. THE HCP USED THE PATIENT PROGRAMMER TO TRY TO THE INS ON, BUT IT STILL SHOWED INS LOW EVEN THOUGH RECHARGER SHOWED >25%. THE HCP WAS ADVISED TO CONTINUE TO CHARGE THE INS PAST 50% AND TRY AGAIN. IT WAS STATED THE HCP REPLACED THE BATTERIES IN THE PATIENT PROGRAMMER BUT THAT DID NOT RESOLVE. IT WAS INDICATED THAT THE HCP CALLED BACK AND STATED THAT THE PATIENT WAS STILL CHARGING AND THEIR INS WAS CHARGED AT 1/4 WITH THE 2ND TILE FLASHING. THE PATIENT'S THERAPY WAS OFF. THE HCP WAS WALKED THROUGH TURNING STIMULATION ON WITH THE RECHARGER. IT WAS STATED THAT THE STIMULATION WAS ON, AND THE PATIENT WAS CHARGING WITH ALL 8 COUPLING BOXES SHADED. IT WAS NOTED THAT THE PATIENT WAS BEING SENT A NEW RECHARGING ANTENNA DUE TO IT BEING DAMAGED.
INFORMATION WAS RECEIVED FROM A FAMILY MEMBER VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING THEIR IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THE PATIENT'S BATTERY WAS TAKING LONGER TO CHARGE. NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS WERE RELATED OR CONTRIBUTED TO THE ISSUE. NO DIAGNOSTICS PERFORMED. NO INTERVENTIONS TO DATE. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) REPORTED THE CONSUMER HADN¿T RAISED ANY CONCERNS REGARDING RECHARGING SINCE (B)(6) 2018, AND THE HCP HAD NO FURTHER INFORMATION TO PROVIDE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE ANTICIPATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 834441 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37612 | 00613994934611 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |