FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2853497
·
Received November 30, 2012
Report
- Report Number
- 3004209178-2012-11025
- Event Type
- Injury
- Date Received
- November 30, 2012
- Report Date
- November 2, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: UNK, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
THE EMERGENCY ROOM (ER) PHYSICIAN REPORTED AN OVERDOSE. AT THE PUMP REFILL ON THE PREVIOUS DAY, (B)(6) 2012, THE DRUG CONTENTS WERE CHANGED AND SINCE THEN THE PATIENT HAD BECOME MORE AND MORE SOMNOLENT OVERNIGHT. THE PHYSICIAN DID NOT HAVE THE DETAILS OF THE DRUG CHANGE THAT WAS MADE BUT WAS TOLD BY THE MANAGING PHYSICIAN TO DECREASE THE DAILY DOSE FROM 0.75ML TO 0.65ML. THE ER PHYSICIAN DID NOT HAVE A PROGRAMMER TO MAKE THE CHANGE. THE PUMP WAS DELIVERING HYDROMORPHONE, CLONIDINE, BUPIVACAINE AND BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |