FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3770099
·
Received April 24, 2014
Report
- Report Number
- 3007566237-2014-01130
- Event Type
- Malfunction
- Date Received
- April 24, 2014
- Date of Event
- April 3, 2014
- Report Date
- April 3, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8703W, LOT# L34928, IMPLANTED: (B)(6) 1995, PRODUCT TYPE CATHETER; PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE THE HEALTH CARE PROVIDER (HCP) WAS PERFORMING TELEMETRY WITH THE 8840 PHYSICIAN PROGRAMMER/PUMP SHE NOTICED THAT THE PUMP WAS INADVERTENTLY UPDATED TO STOPPED PUMP. AFTER TROUBLESHOOTING, IT WAS DETERMINED THE 8840 BATTERIES WERE LOW SO THEY WERE CHANGED. THE PUMP WAS PROPERLY RE-PROGRAMMED AND UPDATED WITH THE CURRENT PUMP SETTINGS AND THE PROGRAMMING WAS CONFIRMED AS CORRECT. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 249080 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00051 YR |