FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3872761
·
Received June 13, 2014
Report
- Report Number
- 3004209178-2014-11585
- Event Type
- Malfunction
- Date Received
- June 13, 2014
- Report Date
- May 23, 2014
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
THIS DATE HAS BEEN UPDATED TO 2014-05-29 FOR THE INITIAL REPORT (MANUFACTURER REPORT # 3004209178-2014-11585).
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PUMP REACHED END OF SERVICE (EOS) AND WAS SENT BACK TO BE DISCARDED. THE CATHETER WAS ALSO RETURNED. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349728 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |