FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2972382
·
Received February 21, 2013
Report
- Report Number
- 3004209178-2013-02953
- Event Type
- Injury
- Date Received
- February 21, 2013
- Report Date
- January 28, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP LOGS REVEALED AN INTERMITTENT MOTOR STALL. THE STALL NEVER RECOVERED. THE PATIENT EXPERIENCED UNDER DOSE SYMPTOMS AND WITHDRAWAL SYNDROMES. THE PATIENT WAS HOSPITALIZED. PATIENT STATUS WAS INDICATED AS ALIVE- WITH INJURY. THE PHYSICIAN WAS ADVISED TO PROGRAM THE PUMP TO A MINIMUM FLOW RATE AND SCHEDULE A REPLACEMENT. SURGICAL INTERVENTION WAS PLANNED. IT WAS CONFIRMED THAT ONLY LABELED DRUGS WERE FILLED INTO THE PUMP DURING ITS LIFETIME. THE PUMP WAS DELIVERING MORPHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76336 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00059 YR | Hospitalization| R |