FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2864237
·
Received December 10, 2012
Report
- Report Number
- 3004209178-2012-11376
- Event Type
- Malfunction
- Date Received
- December 10, 2012
- Report Date
- November 9, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8840, SERIAL # UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 8835, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS INTERRUPTION IN TELEMETRY DURING UPDATE. THE HEALTHCARE PROVIDER (HCP) THOUGHT THAT WHEN THIS WOULD HAPPEN THE PUMP SHOULD RESUME THERAPY IN AN HOUR SO THEY HAD THE PATIENT RETURN IN AN HOUR; HOWEVER, THE PUMP WAS STILL IN STOPPED MODE. THE HCP REPROGRAMMED THE PUMP WHICH RESOLVED THE ISSUE. THE HCP WAS TO RETURN TO THE PATIENT TO FINISH THE UPDATE. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |