ACTIVA
Report
- Report Number
- 3004209178-2021-18515
- Event Type
- Malfunction
- Date Received
- December 14, 2021
- Date of Event
- November 11, 2021
- Report Date
- April 14, 2022
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- UDI-DI
- 00763000310332
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 003
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: A610; SERIAL#: UNKNOWN; PRODUCT TYPE: SOFTWARE. PRODUCT ID: 3389S-40; SERIAL#: (B)(4); IMPLANTED: (B)(6) 2014; PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: A610, SERIAL/LOT #: UNKNOWN; PRODUCT ID: 3389S-40, SERIAL/LOT #: (B)(4). 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.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: A610; SERIAL#: UNKNOWN; PRODUCT TYPE: SOFTWARE. PRODUCT ID: 3389S-40; SERIAL#: (B)(4); IMPLANTED: (B)(6) 2014; PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: A610, SERIAL/LOT #: UNKNOWN; PRODUCT ID: 3389S-40, SERIAL/LOT #: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT IT WAS NOTED THAT THERE IS A SHORT ON 8/9 AT 60 OHMS. IMPEDANCES ARE AS FOLLOWS FOR RIGHT LEAD: C/8 1098, C/9 1098, C/10 849, C/11 992, 8/9 60, 8/10 1179, 8/11 1531, 9/10 1179, 9/11 1531, 10/11 1081. PROGRAMMING FOR RIGHT SIDE IS AS FOLLOWS: R1: 4.3V 80PW, 55HZ C+ 11-; R2: 4.4V, 80PW, 55 HZ, C+10-. IMPEDANCES FOR THE LEFT SIDE ARE IN NORMAL RANGE: C/0 1517, C/1 914, C2 1024, C/3 1501, 0/1 1460, /2 1874, 0/3 2506, 1/2 1111, 1/3 1787, 2/3 1484. PROGRAMMING FOR LEFT LEAD: L1: 4.2V, 80PW, 55HZ C+2-; L2: 4.2V 80PW, 55 HZ C+1-. DISCUSSED HOW THERE ARE NOT A LOT OF PROGRAMMING OPTIONS FOR THE RIGHT LEAD GIVEN THE IMPEDANCES BEING SEEN. MANUFACTURER REPRESENTATIVE (REP) ASKED ABOUT REPLACING THE INS TO WHICH TECHNICAL SERVICES (TS) REVIEWED THE CURRENT SHORT OF 60 OHMS MAY BE INDICATIVE OF AN ISSUE WITH THE LEAD. TS REVIEWED TO CONSIDER TAKING X-RAY OF THE LEAD EXTENSION SITE TO LOOK FOR FRACTURE OR DAMAGE TO THE LEAD. TS DOESN'T BELIEVE THE INS TO BE THE ISSUE IN THIS SITUATION. REP WILL TALK TO HCP FOR NEXT STEPS. SYMPTOMS BEING REPORTED: PATIENT HASN'T HAD MUCH CONTROL LATELY. REPORTS OF DROOLING. HCP IS HAVING A HARD TIME FINDING SETTINGS THAT WORK FOR THE PATIENT. CALLER MENTIONED INFECTION AGAIN BUT NO NEW INFORMATION WAS PROVIDED. (FOR INFORMATION REGARDING INFECTION SEE PE (B)(4).)
ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THE PHYSICIAN TOOK X-RAYS WHICH DIDN¿T SHOW ANYTHING THAT WOULD INDICATE AN ISSUE; THERE WERE A ¿FEW SHARP TURNS IN THE PATH OF THE LEADS, BUT NO UNUSUAL CURVATURES.¿ THE REP WAS UNABLE TO RETRIEVE OR FIND ANY LOGS ASSOCIATED WITH THIS EVENT.
THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THE CAUSE WAS NOT DETERMINED. THE ISSUE WAS NOT RESOLVED. THERE ARE NO PLANNED ACTIONS AT THIS TIME.
IT WAS REPORTED THAT IT WAS NOTED THAT THERE IS A SHORT ON 8/9 AT 60 OHMS. IMPEDANCES ARE AS FOLLOWS FOR RIGHT LEAD: C/8 1098, C/9 1098, C/10 849, C/11 992, 8/9 60, 8/10 1179, 8/11 1531, 9/10 1179, 9/11 1531, 10/11 1081. PROGRAMMING FOR RIGHT SIDE IS AS FOLLOWS: R1: 4.3V 80PW, 55HZ C+ 11-; R2: 4.4V, 80PW, 55 HZ, C+10-. IMPEDANCES FOR THE LEFT SIDE ARE IN NORMAL RANGE: C/0 1517, C/1 914, C2 1024, C/3 1501, 0/1 1460, /2 1874, 0/3 2506, 1/2 1111, 1/3 1787, 2/3 1484. PROGRAMMING FOR LEFT LEAD: L1: 4.2V, 80PW, 55HZ C+2-; L2: 4.2V 80PW, 55 HZ C+1-. DISCUSSED HOW THERE ARE NOT A LOT OF PROGRAMMING OPTIONS FOR THE RIGHT LEAD GIVEN THE IMPEDANCES BEING SEEN. MANUFACTURER REPRESENTATIVE (REP) ASKED ABOUT REPLACING THE INS TO WHICH TECHNICAL SERVICES (TS) REVIEWED THE CURRENT SHORT OF 60 OHMS MAY BE INDICATIVE OF AN ISSUE WITH THE LEAD. TS REVIEWED TO CONSIDER TAKING X-RAY OF THE LEAD EXTENSION SITE TO LOOK FOR FRACTURE OR DAMAGE TO THE LEAD. TS DOESN'T BELIEVE THE INS TO BE THE ISSUE IN THIS SITUATION. REP WILL TALK TO HCP FOR NEXT STEPS. SYMPTOMS BEING REPORTED: PATIENT HASN'T HAD MUCH CONTROL LATELY. REPORTS OF DROOLING. HCP IS HAVING A HARD TIME FINDING SETTINGS THAT WORK FOR THE PATIENT. CALLER MENTIONED INFECTION AGAIN BUT NO NEW INFORMATION WAS PROVIDED. (FOR INFORMATION REGARDING INFECTION SEE PE (B)(4).)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1895690 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37601 | 00763000310332 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Male | "SEE H10...." |