FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3143324
·
Received June 3, 2013
Report
- Report Number
- 3004209178-2013-08569
- Event Type
- Malfunction
- Date Received
- June 3, 2013
- Report Date
- May 8, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A BRIDGE BOLUS WAS NOT PERFORMED. THE CALLER WANTED TO REMOVE THE SYSTEM CONTENTS, SO THE PATIENT WOULD NOT BE LOCKED OUT FROM USING THE PERSONAL THERAPY MANAGER (PTM). IT WAS NOTED THAT THE BRIDGE BOLUS WAS MISSED. THE PUMP WAS BEING USED TO DELIVER HYDROMORPHONE AND BUPIVACAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 244727 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |