FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3932636
·
Received July 14, 2014
Report
- Report Number
- 3004209178-2014-12977
- Event Type
- Malfunction
- Date Received
- July 14, 2014
- Report Date
- June 17, 2014
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A NON-CRITICAL ALARM OCCURRED DUE TO LOW RESERVOIR. THE HEALTH CARE PROVIDER (HCP) HAD MEDICATIONS FOR THE REFILL, BUT THE PATIENT NEEDED TRANSPORTATION. DIAGNOSTIC TESTING/TROUBLESHOOTING WOULD BE PERFORMED IN THE FUTURE. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE NO INJURY AND IT WAS UNKNOWN IF THE PATIENT HAD ANY SYMPTOMS. THE MEDICATION BEING DELIVERED BY THE PUMP WAS NOT SPECIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 409740 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |