FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3192952
·
Received June 27, 2013
Report
- Report Number
- 3004209178-2013-10962
- Event Type
- Malfunction
- Date Received
- June 27, 2013
- Date of Event
- June 3, 2013
- Report Date
- June 3, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT: CATHETER MODEL: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: UNK. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THEY WERE REPORTEDLY ABLE TO ASPIRATE THE RESERVOIR, BUT UNABLE TO FILL IT. THE LOCKED RESERVOIR VALVE PROCEDURE WAS REVIEWED AND HEALTHCARE PROVIDER WAS TO TRY AGAIN AGAIN WITH A DIFFERENT SYRINGE. DRUG DELIVERED VIA THE DEVICE WAS DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 294436 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00049 YR |