SYNCHROMED II
Report
- Report Number
- 3004209178-2019-23787
- Event Type
- Malfunction
- Date Received
- December 13, 2019
- Date of Event
- March 15, 2019
- Report Date
- March 3, 2021
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
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. 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 WAS RECEIVED FROM A FOREIGN HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER'S REPRESENTATIVE (REP) ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT'S PUMP HAD STALLED AND RECOVERED FOUR TIMES. THE LOGS AVAILABLE SHOWED: MOTOR STALL RECOVERY ON (B)(6) 2021 AT 18:30 MOTOR STALL ON (B)(6) 2021 AT 18:24 MOTOR STALL RECOVERY ON (B)(6) 2021 AT 18:29 MOTOR STALL ON (B)(6) 2021 AT 11:51 MOTOR STALL RECOVERY ON (B)(6) 2021 AT 12:10 ACCORDING TO THE REP, NOTHING HAD HAPPENED TO THE PATIENT OR THE ENVIRONMENT TO ACCOUNT FOR THE MOTOR STALL ISSUE.
ADDITIONAL INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER'S REPRESENTATIVE (REP) ON 2021-MAR-03. IT WAS CONFIRMED THAT THE PATIENT'S PREVIOUS MULTIPLE SURGERIES WERE UNRELATED TO THE DEVICE.
ADDITIONAL INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURER'S REPRESENTATIVE (REP) ON (B)(6) 2021. IT WAS REPORTED, THAT THE HCP READ THE LOGS INCORRECTLY, THINKING THAT A MOTOR STALL RECOVERY WAS A STALL, LEADING TO THE REPORT OF 4 MOTOR STALLS OCCURRING. THE PATIENT WOULD BE MONITORED. AND HAD BEEN ADVISED OF PUMP ALARMS, ETC. IN ORDER TO RESOLVE THE MOTOR STALL EVENTS. THE REP NOTED, THAT THE CONSULTANT HAD BEEN ADVISED TO LOOK AT REPLACING THE PUMP, BUT THEY REPORTEDLY, DECIDED NOT TO, DUE TO THE PATIENT HAVING MULTIPLE PREVIOUS SURGERIES. THE PATIENT WAS CONSIDERED DIFFICULT AND COMPLEX. AND THE CONSULTANT WOULD NOT CONSIDER IMPLANTING ANOTHER PUMP. IT WAS REPORTED AGAIN, THAT THE PATIENT WAS USING MORPHINE IN THEIR PUMP AT THE TIME OF THE EVENT.
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.
INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT RECEIVING INTRATHECAL MORPHINE 30.0 MG/ML AT 13.511 MG/DAY VIA AN IMPLANTABLE PUMP. THE INDICATION FOR USE WAS NOT REPORTED. IT WAS REPORTED THAT TWO MOTOR STALLS OCCURRED. LOGS SHOWED: MOTOR STALL ON (B)(6) 2019 AT 21:31, MOTOR STALL RECOVERY ON (B)(6) 2019 AT 21:36, LOW RESERVOIR ALARM ON (B)(6) 2019 AT 04:49, EMPTY RESERVOIR ALARM ON (B)(6) 2019 AT 15:41, MOTOR STALL ON (B)(6) 2019 AT 01:46, MOTOR STALL RECOVERY ON (B)(6) 2019 AT 02:43, MOTOR STALL ON (B)(6) 2019 AT 03:35, MOTOR STALL RECOVERY ON (B)(6) 2019 AT 04:06, MOTOR STALL ON (B)(6) 2019 AT 19:28, MOTOR STALL RECOVERY ON (B)(6) 2019 AT 19:35. THE CAUSE OF THE MOTOR STALL ON (B)(6) 2019 WAS NOT DETERMINED, AND THE PATIENT DID NOT UNDERGO AN MRI ON THAT DAY. THE CAUSE OF THE MOTOR STALLS ON (B)(6) 2019 WAS NOT DETERMINED, AND THE PATIENT DID NOT UNDERGO AN MRI ON THAT DAY. THE CAUSE OF THE EMPTY RESERVOIR ALARM ON (B)(6) 2019 WAS NOT DETERMINED. THE MOTOR STALLS AND EMPTY PUMP HAD NOT BEEN IDENTIFIED AS RESOLVED, AND THERE WAS NO OBVIOUS REASON FOR THEM. THE PATIENT WOULD BE MONITORED AND EDUCATED ON THE PUMP ALARMS. THE HCP WAS CONSIDERING REMOVING THE PUMP. IT WAS FURTHER REPORTED THAT THE PUMP WOULD NOT BE REMOVED IN THE NEAR FUTURE. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS; THE PATIENT WAS ¿FINE AND UNAWARE¿. THE PUMP WAS IMPLANTED IN 2018 (NO FURTHER SPECIFIC DATE AVAILABLE). INFORMATION REGARDING THE PATIENT¿S AGE AND WEIGHT WAS UNAVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1264155 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |