FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 12414343
·
Received September 2, 2021
Report
- Report Number
- 3004209178-2021-13287
- Event Type
- Malfunction
- Date Received
- September 2, 2021
- Report Date
- September 2, 2021
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- UDI-DI
- 00643169508156
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED FOR ANALYSIS. THE PUMP EXCEEDED THE DISPENSE ACCURACY SPECIFICATION BY DISPENSING MORE FLUID THAN THE PROGRAMMED RATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
A 8627-20 PUMP WAS SENT BACK TO THE MANUFACTURER WITH NO KNOWN REPORTED COMPLAINT OR PATIENT HARM. ANALYSIS FOUND ANOMALY THAT INDICATED A COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1312237 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 8637-40 | 00643169508156 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |