FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1872387
·
Received October 11, 2010
Report
- Report Number
- 3004209178-2010-07780
- Event Type
- Malfunction
- Date Received
- October 11, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 13, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- 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 THE DOCTOR WAS UNABLE TO ASPIRATE WATER FROM THE PUMP EVEN AFTER WARNING THE PUMP. COULD ONLY ASPIRATE 10 ML OF WATER FROM A 20 ML PUMP. AFTER PUTTING WARM SALINE IN THE PUMP, THE PHYSICIAN WAS ABLE TO EMPTY IT AND THEN PUT DRUG IN IT. THE DOCTOR'S OFFICE HAS NOT REPORTED ANY SYMPTOMS FOR THIS PT. 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 | 53 YR | CATHETER: MODEL 8731, LOT# N001798320| EXPLANTED:| IMPLANTED: |