FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3002221
·
Received March 13, 2013
Report
- Report Number
- 3007566237-2013-00767
- Event Type
- Injury
- Date Received
- March 13, 2013
- Report Date
- February 12, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4). PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PAIN MEDICATION LEVELS HAD BEEN CHANGED ALL THE TIME. THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL FOR WITHDRAWAL AND OVERDOSE MANY TIMES IN THE PAST. THE PATIENT HAD AN UPCOMING APPOINTMENT TO DISCUSS THESE ISSUES WITH THEIR PHYSICIAN. THE DRUG IN THE PUMP WAS UNKNOWN. 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 |
|---|---|---|---|---|---|---|---|
| 105115 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |