FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1082487
·
Received July 25, 2008
Report
- Report Number
- 3004209178-2008-04429
- Event Type
- Injury
- Date Received
- July 25, 2008
- Date of Event
- March 1, 2008
- Report Date
- June 27, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
USED FOR CATHETER.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT BEGAN EXPERIENCING A LOSS OF THERAPEUTIC EFFECT IN MARCH. THE PATIENT WAS EXPERIENCING A RETURN OF PAIN SYMPTOMS. THE PATIENT FELT THE PUMP WAS NOT GIVING MEDICATION AS INTENDED. IN 2008 THE HCP CONFIRMED AN ISSUE. THE DRUG USED IN THE PUMP IS MORPHINE 10 MG/DL AT A DOSE OF 2.0 MG/DAY. THE CATHETER WAS REPLACED IN 2008.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | CATHETER MODEL 8709SC| IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER MODEL 8840 LOT# UNKNOWN| EXPLANTED: |