FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1812459
·
Received August 16, 2010
Report
- Report Number
- 3004209178-2010-06133
- Event Type
- Injury
- Date Received
- August 16, 2010
- Date of Event
- July 14, 2010
- Report Date
- July 14, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PUMP WAS REPLACED AS IT HAD RAN DRY DUE TO BEING UNMANAGED. A DYE STUDY WAS PERFORMED, HOWEVER, RESULTS WERE NOT INDICATED. THE PT HAD RECOVERED WITHOUT SEQUELA. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention | IMPLANTED:| CATHETER: MODEL 8578, LOT# N250107005| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N149967017| EXPLANTED:| IMPLANTED: |