FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2030442
·
Received March 9, 2011
Report
- Report Number
- 3004209178-2011-01772
- Event Type
- Malfunction
- Date Received
- March 9, 2011
- Date of Event
- February 1, 2011
- Report Date
- February 21, 2011
- 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
A CONFIRMED PUMP MOTOR STALL WAS NOTED IN THE EVENT LOGS WITH NO MOTOR STALL RECOVERY RECORDED. THE LAST STAFF WAS ON (B)(6) 2011. A PUMP REPLACEMENT WAS PLANNED. NO PT SYMPTOMS WERE REPORTED. THE PUMP WAS USED TO DELIVER MORPHINE AND BUPIVICAINE. ADD'L INFO HAS 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 | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | CATHETER: MODEL 8709SC, LOT# N174804019| EXPLANTED:| IMPLANTED: |