SYNCHROMED II
Report
- Report Number
- 3004209178-2019-13851
- Event Type
- Malfunction
- Date Received
- July 19, 2019
- Report Date
- July 30, 2019
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- UDI-DI
- 00643169100831
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
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 CONSUMER (FRIEND / FAMILY MEMBER OF PATIENT) REGARDING A PATIENT WHO WAS RECEIVING AN UNSPECIFIED DRUG OF UNSPECIFIED CONCENTRATION AT AN UNSPECIFIED DOSE RATE VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THE PATIENT¿S PUMP WAS EMPTY DUE TO NOT BEING ABLE TO FIND A DOCTOR TO FILL HER PUMP. THE DATE OF THE EVENT WAS NOT SPECIFIED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT. IT WAS REPORTED THAT PATIENT WAS HEARING A MULT-TONE ALARM, HOWEVER PATIENT DID NOT HAVE MEDICATION IN PUMP FOR TWO YEARS, SO IT HAD BEEN RUNNING DRY FOR THIS TIME PERIOD. PUMP HAD BEEN RUNNING DRY FOR TWO YEARS AS PATIENT WAS NOT ABLE TO FIND A NEW MANAGING HCP. PATIENT WAS SCHEDULED FOR A MAGNETIC RESONANCE IMAGING (MRI). NO FURTHER COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 603087 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 8637-20 | 00643169100831 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |