FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1872393
·
Received October 11, 2010
Report
- Report Number
- 3004209178-2010-07816
- Event Type
- Malfunction
- Date Received
- October 11, 2010
- Date of Event
- July 1, 2010
- Report Date
- July 2, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD A PROBLEM WITH HIS PUMP. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. THE HEALTH CARE PROFESSIONAL CONFIRMED A MOTOR STALL WITH OUT RECOVERY. PER HCP, THE MOTOR STALL WAS "CAUSED BY PT HAVING MRI OR OTHER MEDICAL PROCEDURE." ADD'L INFO HAS BEEN REQUESTED, A F/U 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 | 8637 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N255146013| IMPLANTED:| PROGRAMMER: MODEL 8835, LOT# NPG017562N| EXPLANTED: |