ACTIVA
Report
- Report Number
- 3004209178-2021-04325
- Event Type
- Malfunction
- Date Received
- March 15, 2021
- Date of Event
- December 19, 2019
- Report Date
- February 20, 2023
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- UDI-DI
- 00643169864238
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- 003
Narratives
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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.
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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.
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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.
ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THE REPLACEMENT RECHARGER DIDN¿T RESOLVE THE ISSUE, INSTEAD THE MANUFACTU RER¿S REPRESENTATIVE (REP) BROUGHT A HANDSET TO SOLVE THE PROBLEM. THE HANDSET MADE A BETTER CONNECTION WHICH DECREASED THE CHARGING TIME. THE PATIENT DIDN¿T THINK THE STOMACH WAS THE PLACE FOR A DBS SUTURE.
ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE RECHARGER LIGHT IS GREEN AND THEN LIGHT TURNS AMBER. IT STARTED LAST WEEK A COUPLE TIMES. PATIENT SHUT IT OFF FOR A COUPLE HOURS AND THEN IT WORKED. PATIENT STATES RECHARGER IS FULLY CHARGED. DURING CALL, PATIENT PLACED RECHARGER OVER INS IN RIGHT SIDE CHEST AND RECHARGER DISCONNECTED FROM INS, THEN CONNECTED AFTER PATIENT PLACED RECHARGER IN DRAPE. RECHARGER APP SHOWED INS WAS 75% CHARGED WITH EXCELLENT CONNECTION. PATIENT STATES INS IMPLANTED IN STOMACH GIVES HIM THE MOST TROUBLE. PATIENTS STATES INS WAS IMPLANTED ON THE LEFT SIDE CHEST BUT THEN GOT INFECTION WHEN INS WAS REPLACED AND INS WAS MOVED TO THE STOMACH (SEE 704281598 FOR DOCUMENTATION.) PATIENT STATES NOTICING THE INS MOVES AROUND THE FIRST TIME RECHARGING IN 2019. DURING CALL PATIENT TRIED RECHARGING INS LOCATED IN STOMACH BUT COULD NOT GET IT CONNECTED. PATIENT STATES SOMETIMES RECHARGER WILL CONNECT TO INS RIGHT AWAY AND SOMETIMES IT WON'T. PATIENT STATES WIRELESS RECHARGER WORKS BETTER THAN THE 37751 RECHARGER. PATIENT STATES RECHARGING WORKS BEST WHEN HE MOVES INS TO THE SIDE AND SITTING IN A RECLINER OR STANDING UP. PATIENT STATES HE USED TO CHARGE EVERY 3 DAYS BUT IT WAS TAKING SO LONG PATIENT NOW CHARGES ONCE A DAY. PATIENT THINKS INS IS AT ABOUT 75%. PATIENT STATES INFORMING DOCTOR AND NOTHING WAS SAID. PATIENT STATES PREVIOUS DOCTOR LEFT AND PATIENT IS GOING TO SEE A NEW DOCTOR IN FEBRUARY AND WILL DISCUSS ISSUE.
ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED TO RESOLVE THE CHARGING ISSUE THE SYSTEM WAS REPLACED (RECHARGER) AND WAS NOW OKAY.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THEIR LEFT SIDE IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANTED IN THEIR ABDOMEN "SEEMS LIKE IT MOVES AROUND" IN THE POCKET. AS A RESULT, THEY HAVE BEEN DEALING WITH POOR COUPLING WHEN THEY CHARGE THE LEFT SIDE INS. THEY HAVE 2 RECHARGERS, ONE FOR EACH INS. REGARDLESS OF WHICH RECHARGER THEY USE, THEY OCCASIONALLY CAN GET 8 COUPLING BOXES TO FILL IN WHEN THEY CHARGE THE LEFT SIDE INS, BUT THEN THEY GRADUALLY LOSE THE COUPLING BOXES. AS A RESULT, IT CURRENTLY TAKES MORE THAN AN HOUR AND A HALF TO CHARGE THE LEFT SIDE INS. THE PATIENT MENTIONED THAT THEY HOLD THEIR RECHARGER ANTENNA BY HAND OVER THE LEFT SIDE INS. THEY HAVE ALREADY ROTATED THE ANTENNA DIAL AND REPOSITIONED THE ANTENNA, BUT THESE ACTIONS ONLY TEMPORARILY RESOLVE THE COUPLING ISSUE. THE PATIENT STATED THAT THEY ALSO HAVE A COUPLING ISSUE WHILE CHARGING THE RIGHT SIDE INS ON THEIR RIGHT SIDE, BUT ONLY WHEN USING ONE OF THE RECHARGERS. THE PATIENT DID NOT EXPRESS ANY POCKET CONCERNS REGARDING THE RIGHT SIDE INS, WHICH IS IMPLANTED IN THEIR CHEST. THEIR HCP IS AWARE OF THIS ISSUE AND ADVISED THE PATIENT TO CALL FOR ASSISTANCE. DURING THE CALL, THE PATIENT USED THE RECHARGER TO CHARGE THE LEFT SIDE INS. THE PATIENT INITIALLY GOT 2 COUPLING BOXES TO FILL IN, THEN NO COUPLING BOXES AFTER REPOSITIONING THE ANTENNA, THEN 6 COUPLING BOXES AFTER ROTATING THE ANTENNA, BUT THE COUPLING CONTINUED TO FLUCTUATE. THE ISSUE WAS NOT RESOLVED. A REPLACEMENT RECHARGER WAS SENT. THE PATIENT WAS ALSO REDIRECTED TO THEIR MANAGING HCP TO FURTHER ADDRESS THE ISSUE WITH THE LEFT SIDE INS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 377020 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37612 | 00643169864238 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male |