FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1915543
·
Received November 5, 2010
Report
- Report Number
- 3004209178-2010-08923
- Event Type
- Malfunction
- Date Received
- November 5, 2010
- Date of Event
- October 1, 2010
- Report Date
- October 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 THE PT'S PUMP DEVICE HAD A MOTOR STALL WHICH WAS CONFIRMED IN THE LOGS. NO RECOVERY WAS NOTED. IT WAS STATED THE PUMP WAS IN SAFE STATE, AND A LOW BATTERY WAS REPORTED. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | CATHETER: MODEL 8709, LOT#: J12363R25| EXPLANTED:| IMPLANTED: |