SYNCHROMED II
Report
- Report Number
- 3004209178-2012-08883
- Event Type
- Injury
- Date Received
- October 4, 2012
- Report Date
- September 13, 2012
- Manufacturer
- MDT 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
(B)(4).
PRODUCT ID 8709SC, LOT# H825097210, IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER (B)(4).
IT WAS REPORTED THAT THERE WAS A CATHETER REVISION AND SUBSEQUENTLY AN INFECTION AND PUMP SYSTEM EXPLANT. ON (B)(6) 2012, IT WAS REPORTED THAT PATIENT WAS TAKEN TO THE OPERATING ROOM TO RE-ANCHOR THE CATHETER AT THE BACK CATHETER SITE. THE CAUSE/NEED FOR THE CATHETER ANCHOR REVISION WAS NOT PROVIDED. FOLLOWING THE REVISION, THE PATIENT WAS DISCHARGED WITH NO ISSUES AND WAS DOING WELL UP UNTIL (B)(6) 2012 WHEN THEY DEVELOPED A FEVER OF 103F. BY (B)(6) 2012 THE PATIENT DEVELOPED REDNESS AT THE PUMP POCKET SITE WHICH EXTENDED TO BACK INCISION AREA. PATIENT WAS TAKEN TO THE HOSPITAL AND WAS ADMITTED TO THE NURSING UNIT. THE HEALTHCARE PROVIDER THEN EXPLANTED THE PUMP AND CATHETER ON (B)(6) 2012 DUE TO INFECTION. CULTURES WERE SENT OFF FROM THE PUMP POCKET AND BACK INCISION SITES. THE PATIENT WAS PLACED ON ORAL BACLOFEN 20 MG THREE TIMES A DAY TO SUPPLEMENT PUMP THERAPY. THE PATIENT WAS ADMITTED TO THE NURSING UNIT STABLE FOLLOWING THE EXPLANT SURGERY. THE MEDICATION IN THE PUMP WAS LIORESAL (BACLOFEN). 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 | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00008 YR | Hospitalization| R |