FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1990847
·
Received February 8, 2011
Report
- Report Number
- 3004209178-2011-00956
- Event Type
- Injury
- Date Received
- February 8, 2011
- Date of Event
- January 1, 2011
- Report Date
- February 4, 2011
- 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
- ME, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT WAS HOSPITALIZED "(B)(6)" DUE TO WITHDRAWAL. WHEN THE PUMP WAS INTERROGATED, IT WAS DISCOVERED THAT THE PUMP WAS EMPTY. THE PT'S NEXT REFILL WASN'T SCHEDULED UNTIL (B)(6) 2011; NO ALARM SOUNDED FROM THE PUMP. THE PHYSICIAN REFILLED THE PUMP, BUT THEY DID NOT DISCUSS WHAT FURTHER TROUBLESHOOTING WOULD BE DONE TO DETERMINE THE CAUSE OF THE INCIDENT. IT WAS NOTED THAT THE SAME INCIDENT HAPPENED LAST YEAR (SEE MFR'S REPORT # 3004209178201100955). THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. A FOLLOW-UP 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 | 27 YR | Hospitalization| O | EXPLANTED:| IMPLANTED:| LOT# NGV415587H| CATHETER: MODEL 8709, LOT# J11609R51| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8578, LOT# N147409| EXPLANTED:| IMPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 863740, |