FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1052611
·
Received May 27, 2008
Report
- Report Number
- 3004209178-2008-02826
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- January 1, 2007
- Report Date
- April 25, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
THE PATIENT STATED THAT THE WRONG MEDICATION WAS PUT IN HIS PUMP. THIS CAUSED HIM TO FALL A LOT AND EVENTUALLY HE ENDED UP IN THE ICU. THE PATIENT FELL IN 2007 AND SINCE THEN, THE PATIENT WAS CURRENTLY AT HOME AND HIS STATUS WAS "GOOD". THE TYPE OF MEDICATION BEING DELIVERED VIA THE PUMP WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 8637 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Hospitalization| L| R | EXPLANTED:| IMPLANTED:| CATHETER MDOEL 8709AA LOT# N089093034| PROGRAMMER MODEL 8840 LOT# UNKNOWN |