FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3204202
·
Received July 3, 2013
Report
- Report Number
- 3004209178-2013-06179
- Event Type
- Malfunction
- Date Received
- July 3, 2013
- Date of Event
- June 20, 2012
- Report Date
- April 11, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8590-1, LOT# N182450, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709SC, LOT# N175922015, IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PUMP HAD A CONFIRMED MOTOR STALL AND MOTOR STALL RECOVERY RECORDED IN THE EVENT LOGS. THE MOTOR STALL WAS CAUSED BY THE PATIENT HAVING AN MRI OR OTHER MEDICAL PROCEDURE AND THE PUMP WAS FUNCTIONING AS INTENDED. NO FURTHER INFORMATION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 306587 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00045 YR |