FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3436523
·
Received October 30, 2013
Report
- Report Number
- 3004209178-2013-19855
- Event Type
- Malfunction
- Date Received
- October 30, 2013
- Report Date
- October 11, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8590-1, LOT# N201184, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A "CATHETER ISSUE" IN (B)(6) 2013 FROM A CAR ACCIDENT. THE REPORTER NOTED THERE WAS A CRACK IN THE CATHETER. THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS NOT SPECIFIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 557870 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00033 YR |