FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2864007
·
Received December 10, 2012
Report
- Report Number
- 3004209178-2012-11350
- Event Type
- Injury
- Date Received
- December 10, 2012
- Report Date
- November 8, 2012
- 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
- TN, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID, 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID, 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2003 (B)(6), PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S MAGNETIC RESONANCE IMAGING (MRI) SCAN WAS STOPPED DUE TO THE PATIENT'S COMPLAINT OF HEATING SENSATION OVER THE PUMP POCKET SITE. THE HEALTH CARE PROVIDER FELT THE PUMP SITE AND AGREED THAT THE SITE WAS "HOT". THE PATIENT WAS GETTING THE MRI FOR INCREASED SHOULDER PAIN THAT WAS REPORTED AS UNRELATED TO THE DEVICE SYSTEM. ACCORDING TO THE MANUFACTURER DEVICE REGISTRY, THE DRUG DELIVERED VIA PUMP WAS DILAUDID. ADDITIONAL INFORMATION HAD BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE 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 | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |