SYNCHROMED II
Report
- Report Number
- 3004209178-2017-16396
- Event Type
- Malfunction
- Date Received
- August 8, 2017
- Date of Event
- August 7, 2017
- Report Date
- September 1, 2017
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- UDI-DI
- 00643169508156
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- PHYSICIAN
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8578, (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER, PRODUCT ID: 8709, (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: CATHETER . 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.
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 REPORTED THAT THE PATIENT¿S LAST REFILL WAS (B)(6) 2017.THE PUMP WAS USED TO DELIVER GABLOFEN 2000MCG/ML AT 600MCG/DAY, LOT NUMBER 2163-121. IT WAS NOTED THAT THE PATIENT WAS NOTED TO BE TIGHT AND IRRITABLE AT THE APPOINTMENT ON (B)(6) 2017. THE ACTUAL RESIDUAL VOLUME WAS 31 ML AND THE EXPECTED RESERVOIR VOLUME PER THE PROGRAMMER WAS 4.7ML. THE INTRATHECAL BACLOFEN WAS NOT DISCONTINUED AS THE PATIENT¿S PUMP WAS REFILLED AND THE RATE SET AT 630MCG/DAY. THE PATIENT HAD A SIDEPORT ACCESS PERFORMED AND IT APPEARED THE CATHETER WAS NOT PATENT. THE PATIENT WAS REFERRED TO NEUROSURGERY FOR POSSIBLE CATHETER REVISION. THE GUARDIAN OF THE PATIENT REQUESTED TO TRY ORAL BACLOFEN AND IF SUCCESSFUL, THE PUMP WAS TO BE REMOVED. THE PATIENT¿S MEDICAL HISTORY INCLUDED CP (CEREBRAL PALSY) WITH SPASTIC QUADRIPLEGIA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT PATIENT/CAREGIVER HAS DECIDED TO WAIT TO DO ANY INTERVENTION AT THIS TIME. THE PATIENT WAS BEING MANAGED ON ORAL BACLOFEN WITH NO SURGICAL INTERVENTION PLANNED.
ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2017 FROM A HEALTHCARE PROFESSIONAL WHO REPORTED THAT IT WAS UNKNOWN IF THE CAUSE OF THE VOLUME DISCREPANCY HAD BEEN DETERMINED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
ADDITIONAL INFORMATION WAS RECEIVED ON 29-AUG-2017 AND IT WAS REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2017. PER THE PATIENT¿S HEALTHCARE PROVIDER, THE PATIENT¿S PASSING DID NOT HAVE ANYTHING TO DO WITH HER PUMP. SHE HAD BEEN HAVING OTHER MEDICAL ISSUES THAT LEAD TO HER DEATH.
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING BACLOFEN VIA AN IMPLANTED PUMP. THE INDICATION FOR PUMP USE WAS CEREBRAL PALSY AND INTRACTABLE SPASTICITY. ON (B)(6) 2017 IT WAS REPORTED THAT THE ACTUAL RESIDUAL VOLUME (30 ML) WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME (4.9 ML). THIS WAS THE FIRST REFILL SINCE THE PUMP WAS IMPLANTED IN (B)(6) 2017. THE EVENT LOGS WERE CHECKED AND NO ISSUES WERE NOTED IN THE EVENT LOGS. THE PATIENT WAS NON-VERBAL BUT SEEMED TIGHT AND IRRITABLE PER THE HCP. IT WAS NOTED THAT THE PATIENT HAD RECURRING UTIS (URINARY TRACT INFECTIONS) AND CURRENTLY HAD A KIDNEY STONE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 554259 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 8637-40 | 00643169508156 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR |