FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2792574
·
Received October 16, 2012
Report
- Report Number
- 3004209178-2012-09217
- Event Type
- Injury
- Date Received
- October 16, 2012
- Date of Event
- August 8, 2012
- Report Date
- September 24, 2012
- 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
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PRODUCT ID, 8703W LOT# L70872 SERIAL#, IMPLANTED: 1999 (B)(6), EXPLANTED: PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED BACLOFEN WITHDRAWAL. IT WAS INDICATED THAT THE PATIENT MISSED HER REFILL APPOINTMENT AND THE EMPTY RESERVOIR ALARM OCCURRED ON (B)(6) 2012. THE PUMP WAS INTERROGATED, AND THE INTERROGATED RESERVOIR VOLUME READ "0ML". THE PATIENT WAS PRESENTED TO THE EMERGENCY ROOM (ER) WITH ALTERED MENTAL STATUS AND HAD REQUIRED HOSPITALIZATION. IT WAS INDICATED THAT THE PUMP WAS REFILLED AND A 50MCG BOLUS WAS GIVEN. THE OUTCOME OF THE PATIENT WAS REPORTED AS RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00055 YR | Hospitalization| R |