FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3202727
·
Received July 2, 2013
Report
- Report Number
- 3004209178-2013-04751
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- May 16, 2012
- Report Date
- May 23, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8598A, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A MAGNETIC RESONANCE IMAGING (MRI) DONE ON (B)(6) 2012 TO RULE OUT GRANULOMA. THE RESULT WAS ¿NEGATIVE.¿ A MOTOR STALL OCCURRED POST MRI. THE MOTOR STALL RECOVERY WAS NOT NOTED UNTIL THE DATE OF THIS REPORT. THE PATIENT DID NOT HEAR ANY ALARMS. PATIENT OUTCOME WAS NOTED AS NO INJURY. THE PUMP WAS USED TO DELIVER MORPHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301837 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00040 YR |