FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2925529
·
Received January 22, 2013
Report
- Report Number
- 3004209178-2013-00839
- Event Type
- Injury
- Date Received
- January 22, 2013
- Date of Event
- April 15, 2012
- Report Date
- January 2, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION REPORTED THAT THE PATIENT¿S MANAGING PHYSICIAN NEVER TREATED THE PATIENT FOR AN INFECTION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION NEAR THE POCKET SITE ABOUT TWO WEEKS AFTER THE INITIAL IMPLANT. IT WAS NOTED THAT, AT THIS TIME, THE PATIENT WAS GETTING 'REALLY HOT' AND THE PUMP AREA WAS BRIGHT RED AND PAINFUL. ALSO, THE PATIENT HAD THREE ORAL YEAST INFECTIONS SINCE IMPLANT. THE PATIENT WAS HOSPITALIZED AND HAD HER PUMP REMOVED, CLEANED, AND RE-IMPLANTED. AFTER THE PROCEDURE, THE PATIENT HAD 'TWO PIECES OF (B)(6) INFECTION.'
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30031 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00054 YR | Hospitalization| R |