FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2994001
·
Received March 8, 2013
Report
- Report Number
- 3004209178-2013-03470
- Event Type
- Injury
- Date Received
- March 8, 2013
- Report Date
- February 8, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2006-01-04 EXPLANTED: PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT REQUIRED HOSPITALIZATION FOR REPLACEMENT. THE PUMP AND CATHETER WERE REMOVED IN (B)(6) 2012 AND WERE REPLACED. THE PUMP WAS BEING USED TO DELIVER LIORESAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT, ABOUT TWO MONTHS PRIOR TO THIS REPORT, THE PATIENT'S PUMP WAS REMOVED AFTER THE DEVELOPMENT OF A POST-OPERATIVE INFECTION. THE PATIENT'S OUTCOME WAS NOT KNOWN. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS SUBMISSION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98738 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |