FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3141352
·
Received June 3, 2013
Report
- Report Number
- 3004209178-2013-08508
- Event Type
- Injury
- Date Received
- June 3, 2013
- Report Date
- May 12, 2013
- 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
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP HAD NUMEROUS MOTOR STALLS IN THE PAST WEEK; ONE STALL LASTED ALMOST 24 HOURS BEFORE IT RECOVERED. THE PUMP WAS REPLACED. THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THE EVENT. THE PATIENT STATUS WAS REPORTED AS ¿ALIVE - NO INJURY/NO ADVERSE EVENT¿. THE PUMP WAS DELIVERING LIORESAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 244514 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00068 YR | Required Intervention |