ACTIVA
Report
- Report Number
- 3004209178-2021-17048
- Event Type
- Injury
- Date Received
- November 15, 2021
- Date of Event
- March 16, 2021
- Report Date
- May 8, 2026
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- UDI-DI
- 00643169963412
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CONTINUATION OF D10: PRODUCT ID 0913025 LOT# S2871-01 SERIAL# IMPLANTED: (B)(6) 2020,EXPLANTED: PRODUCT TYPE PRODUCT ID 0913025 LOT# S2852-08 SERIAL# IMPLANTED: (B)(6)2020, EXPLANTED: PRODUCT TYPE PRODUCT ID 3708760 LOT# SERIAL# (B)(6), IMPLANTED: (B)(6) 2020,EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID 3708760 LOT# SERIAL# (B)(6), IMPLANTED: (B)(6) 2020, EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID 0913025 LOT# S2871-01 SERIAL# IMPLANTED: (B)(6) 2020, EXPLANTED: PRODUCT TYPE PRODUCT ID 0913025 LOT# S2852-08 SERIAL# IMPLANTED: (B)(6) 2020, EXPLANTED: PRODUCT TYPE. 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.
CORRECTION TO SHOW THAT IT WAS CONSIDERED "SPECULATION" THAT THE LEAD WAS BROKEN, NOT TECHNICALLY "SUSPECTED." 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.
CONTINUATION OF D10: PRODUCT ID 0913025 LOT# S2871-01 SERIAL# IMPLANTED: 2020(B)(6) EXPLANTED: PRODUCT TYPE PRODUCT ID 0913025 LOT# S2852-08 SERIAL# IMPLANTED: 2020-(B)(6) EXPLANTED: PRODUCT TYPE PRODUCT ID 3708760 LOT# SERIAL# (B)(6) IMPLANTED: 2020-(B)(6) EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID 3708760 LOT# SERIAL# (B)(6) IMPLANTED: 2020-(B)(6) EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID 0913025 LOT# S2871-01 SERIAL# IMPLANTED: 2020-(B)(6) EXPLANTED: PRODUCT TYPE PRODUCT ID 0913025 LOT# S2852-08 SERIAL# IMPLANTED: 2020-(B)(6) EXPLANTED: PRODUCT TYPE 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.
CONTINUATION OF D10: PRODUCT ID 0913025, LOT# (B)(6), IMPLANTED: (B)(6) 2020, PRODUCT ID 0913025, LOT# S2852-08, IMPLANTED: (B)(6) 2020, PRODUCT ID 3708760, SERIAL# (B)(6), IMPLANTED: (B)(6) 2020, PRODUCT ID 3708760, SERIAL# (B)(6), IMPLANTED: (B)(6) 2020, PRODUCT ID 0913025, LOT# S2871-01, IMPLANTED: (B)(6) 2020, PRODUCT ID 0913025, LOT# S2852-08, IMPLANTED: (B)(6) 2020. 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.
CONTINUATION OF D10: PRODUCT ID 0913025 LOT# S2871-01 SERIAL# IMPLANTED: (B)(6) 2020 EXPLANTED: PRODUCT TYPE PRODUCT ID 0913025 LOT# S2852-08 SERIAL# IMPLANTED: (B)(6) 2020 EXPLANTED: PRODUCT TYPE PRODUCT ID 3708760 LOT# SERIAL# (B)(6) IMPLANTED: (B)(6) 2020 EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID 3708760 LOT# SERIAL# (B)(6) IMPLANTED: (B)(6) 2020 EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID 0913025 LOT# S2871-01 SERIAL# IMPLANTED: (B)(6) 2020 EXPLANTED: PRODUCT TYPE PRODUCT ID 0913025 LOT# S2852-08 SERIAL# IMPLANTED: (B)(6) 2020 EXPLANTED: PRODUCT TYPE 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: 0913025, LOT# S2871-01, IMPLANTED: (B)(6) 2020, PRODUCT TYPE. PRODUCT ID: 0913025, LOT# S2852-08, IMPLANTED: (B)(6) 2020, PRODUCT TYPE: SECTION. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 0913025, SERIAL/LOT #: (B)(4), UBD: 28-MAR-2023, UDI#: (B)(4); PRODUCT ID: 0913025, SERIAL/LOT #: (B)(4), UBD: 28-MAR-2023, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE PATIENT WAS SEEN ON (B)(6)2021 AND ASKED TO EXTEND THEIR LEFT ARM (CLOSEST TO THE IMPLANT) VENTRALLY, LATERALLY AND PROXIMALLY, AS WELL AS STRETCH OUT THEIR NECK, AND RESTING. DURING ALL OF THOSE MOVEMENTS/POSITIONS THE IMPEDANCES REMAINED HIGH ON CONTACTS E2 AND E3. IT WAS SUSPECTED THAT THE HIGH IMPEDANCES WERE MEANING THE ELECTRODES FOR E2 AND E3 WERE BROKEN AND STIMULATING/SENSING THOSE CONTACTS WAS NOT A GOOD IDEA. THE STIMULATION WOULD NOT BE DELIVERED TO THE CORTEX OR AT LEAST NOT AS INTENDED. THE PROBLEM WAS PERSISTING AND THE CAUSE OF THE IMPEDANCES COULD NOT YET BE DETERMINED.
ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE PATIENT WAS SEEN ON (B)(6) 2021 AND ASKED TO EXTEND THEIR LEFT ARM (CLOSEST TO THE IMPLANT) VENTRALLY, LATERALLY AND PROXIMALLY, AS WELL AS STRETCH OUT THEIR NECK, AND RESTING. DURING ALL OF THOSE MOVEMENTS/POSITIONS THE IMPEDANCES REMAINED HIGH ON CONTACTS E2 AND E3. IT WAS SPECULATED THAT THE HIGH IMPEDANCES WERE MEANING THE ELECTRODES FOR E2 AND E3 WERE BROKEN AND STIMULATING/SENSING THOSE CONTACTS WAS NOT A GOOD IDEA. THE STIMULATION WOULD NOT BE DELIVERED TO THE CORTEX OR AT LEAST NOT AS INTENDED. THE PROBLEM WAS PERSISTING AND THE CAUSE OF THE IMPEDANCES COULD NOT YET BE DETERMINED.
ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT X-RAY IMAGES WERE TAKEN BUT COULDN'T SEE ANYTHING STRANGE. THEY THOUGHT A CT SCAN WOULD BE BETTER.
ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT IN THE LAST VISIT IN APRIL THE PATIENT'S IMPEDANCES WERE ALL NORMAL AND STABLE. IF THE PROBLEM DIDN'T SHOW UP ANYMORE THE SITE WOULDN'T INVESTIGATE ANY FURTHER.
ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT AFTER THE CT SCAN, THEY HAD ONE VISIT IN APRIL IN WHICH THE IMPEDANCES WERE AGAIN STABLE. HOWEVER, FURTHER VISITS WERE NEEDED TO CONFIRM THAT THE ISSUE IS GONE AWAY BUT NO MORE ISSUES WERE HEARD FROM THE SITE. THE VISITS WERE PLANNED ONCE PER MONTH.
IT WAS REPORTED THAT IMPEDANCE WAS UNSTABLE ON ELECTRODES 2 AND 3 FOR THE LAST COUPLE MONTHS PRIOR TO REPORT. THESE ELECTRODES WERE USED FOR STIMULATION, SO IT COULD INFLUENCE STIMULATION EFFICACY TO ABORT SEIZURES. A CLINIC VISIT WAS SCHEDULE FOR (B)(6) 2021, IN WHICH THEY WOULD MEASURE IMPEDANCES WHILE PATIENT WAS RELAXING AND STRETCHING TO INVESTIGATE ANY IMPEDANCE CHANGES. ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE IMPEDANCES WERE INDEED >10,000 OHMS AND THEREFORE PLOTTED AS 10,000. THE PATIENT DIDN'T EXPERIENCE ANY ISSUES. THEY THOUGHT THE IMPEDANCES WERE DUE TO MEASUREMENTS. THE STIMULUS CURRENT THAT WAS APPLIED WAS LOWER THAN NORMAL WHICH COULD HAVE RESULTED IN LESS EFFECTIVE STIMULATION. FURTHERMORE, THEY NOTICED THAT THE STIMULUS ARTIFACT (WHICH WAS SUBTRACTED IN THE LINEAR ALGORITHM TO STOP SEIZURE DETECTION WHEN STIMULATION WAS STARTED) WAS LOWER THAN IN PRIOR MEASUREMENTS, WHICH LED TO LONGER STIMULATION THAN PREVIOUSLY. THEY PATIENT DIDN'T EXPERIENCE THOSE STIMULATIONS. THE PATIENT WAS IMPLANTED FOR THERAPY RESISTANT FOCAL EPILEPSY. IT WAS NOTED STARTING (B)(6) 2021, THERE WAS HIGH IMPEDANCE AROUND 10,000 OHMS, BUT THIS RETURNED TO NORMAL RANGE BETWEEN (B)(6) 2021 AND (B)(6) 2021.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 23333 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37604 | 00643169963412 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | "SEE H10...." |