FDA Adverse Event
Summary report: N
MEDTRONIC
MDR report key: 512653
·
Received January 23, 2004
Report
- Report Number
- MW4003678
- Date Received
- January 23, 2004
- Date of Event
- February 1, 2000
- Report Date
- October 31, 2003
- Manufacturer
- MEDTRONIC, INC. / NEUROLOGICAL & SPINAL DIV.
- Product Code
- LKK
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
COMPLAINANT ALLEGES THAT MANUFACTURER HAS NOT PROPERLY REPORTED INFO REGARDING ADVERSE EVENTS INVOLVING MEDTRONIC'S SYNCHROMED INFUSION DEVICE. COMPLAINANT STATES THEY HAD DEVICE SURGICALLY IMPLANTED IN 2000 TO TREAT INTRACTABLE BACK PAIN. THEY STATED THAT THEY SUFFERED A SERIES OF ADVERSE EVENTS AFTER THEIR PHYSICIAN ORDERED AN UNAPPROVED COMBINATION OF MEDICATIONS TO BE INFUSED VIA THE PUMP. COMPLAINANT BELIEVES MEDTRONIC MAY NOT BE REPORTING ALL ADVERSE EVENTS INVOLVING THE USE OF THIS DEVICE AND IS NOW REPORTING SUCH EVENTS UNDER A FICTITIOUS DEVICE MANUFACTURER KNOWN AS RICE CREEK MANUFACTURING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDTRONIC | SYNCHROMED | LKK | MEDTRONIC, INC. / NEUROLOGICAL & SPINAL DIV. | * | NGF005723R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |