FDA Adverse Event
Death
Summary report: N
SYNCHROMED EL
MDR report key: 409687
·
Received August 8, 2002
Report
- Report Number
- 2182207-2002-00557
- Event Type
- Death
- Date Received
- August 8, 2002
- Date of Event
- July 15, 2002
- Manufacturer
- MEDTRONIC INC.
- Product Code
- LKK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
HCP REPORTED PT SEIZURES AND RESPIRATORY ARREST, REQUIRING INTUBATION, AFTER A REFILL OF 50 MG/ML OF MORPHINE. THE HCP ADMINISTERED TWO BOLUSES OF MARCAINE 7.5 MG EACH THROUGH THE CATHETER ACCESS PORT. THE PT EXPERIENCED PAIN IN LEG IMMEDIATELY AFTER REFILL. THE PT ALSO RECEIVED FENTANYL 600 MCG IV AND VERSED 2 MG IV FOR LEG PAIN. 17-18 CC WERE REMOVED FROM THE PUMP RESERVOIR. THE PT DIED IN THE HOSP ON 7/2002, 12-14 HOURS AFTER THE REFILL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | IMPLANTABLE INFUSION PUMP | LKK | MEDTRONIC INC. | 862718 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Death | CATHETER: MODEL 8703, LOT#J94137423,| EXPLANTED: UNK.| IMLANTED: 1994, |