SYNCHROMED II
Report
- Report Number
- 3004209178-2012-10989
- Event Type
- Injury
- Date Received
- November 30, 2012
- Report Date
- October 31, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
PRODUCT ID 8709SC, SERIAL# (B)(4), EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8703, LOT# J90070744 EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8596SC, SERIAL# (B)(4), EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4). FINAL ANALYSIS OF THE PUMP FOUND NO PUMP ANOMALY. FINAL ANALYSIS OF THE CATHETER DEVICES RETURNED FOUND ACCEPTABLE TESTING, HOWEVER THE CATHETER DEVICES WERE RETURNED INCOMPLETE IN SEGMENTS.
ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS A CATHETER INFECTION AND A YEAST INFECTION IN THE PUMP AREA. THE PATIENT RESOLVED WITHOUT SEQUELA ON (B)(6)-2012. THE INFECTION STARTED RIGHT AFTER A PUMP REPLACEMENT IN (B)(6)-2012. IT WAS REPORTED THE BATTERY ¿WENT BAD.¿
IT WAS REPORTED THAT THE PUMP AND CATHETER WERE REMOVED DUE TO INFECTION. THE PUMP SYSTEM WAS EXPLANTED ON (B)(6) 2012. THE MEDICATION IN THE PUMP WAS DILAUDID. NO OTHER INFORMATION WAS PROVIDED REGARDING THE INFECTION EVENT. 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 |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |