FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1162799
·
Received September 16, 2008
Report
- Report Number
- 3004209178-2008-05781
- Event Type
- Injury
- Date Received
- September 16, 2008
- Date of Event
- February 1, 2008
- Report Date
- August 20, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT DID NOT HAVE ANY SYMPTOMS. DURING A ROUTINE OFFICE VISIT, A NONHEALING WOUND/SKIN EROSION WAS FOUND; THE PUMP RESERVOIR WAS EXPOSED. THE PUMP WAS EXPLANTED. THE PATIENT RECOVERED WITHOUT SEQUELA, AND A NEW PUMP WAS IMPLANTED IN 2008. THE PUMP WAS USED TO DELIVER MORPHINE (20 MG/ML) AT A RATE OF 1.2228 MG/DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention | PROGRAMMER MODEL 8840 LOT# UNKNOWN| CATHETER MODEL 8711 LOT# N077220012 IMPLANTED| EXPLANTED |