SYNCHROMED II
Report
- Report Number
- 3004209178-2013-04593
- Event Type
- Injury
- Date Received
- April 3, 2013
- Report Date
- March 7, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).
PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).
IT WAS REPORTED THAT THERE WAS AN INFECTION OF THE INCISION ABOUT A MONTH AND A HALF AFTER SURGERY. THE INFECTION WAS ALSO IN THE PATIENT'S LEGS AND FEET WHERE IT WAS ACCOMPANIED BY SEVERE SWELLING, NOTABLY WORSE IN THE FEET. THE PATIENT WAS PUT ON ANTIBIOTICS INCLUDING VIOMYCIN AND THE PUMP WAS EXPLANTED. IT WAS STATED THAT THE THERAPY HAD BEEN WORKING FOR THE PATIENT, SO THE EXPLANT HAD BEEN DELAYED TO TRY AND SAVE THE PUMP. THE DRUG USED IN THIS SYSTEM WAS UNKNOWN.
IT WAS REPORTED THAT THE DOCTOR THAT PERFORMED THE PUMP TRIAL WAS DIFFERENT THAN THE DOCTOR THAT IMPLANTED THE PUMP AND TREATED THE PATIENT. IT WAS REPORTED THAT NO PREOPERATIVE ANTIBIOTICS WERE ADMINISTERED. THE PUMP WAS REFILLED ON (B)(6) 2013. THERE WAS NO MENINGITIS REPORTED. THE PUMP WAS INFUSING MORPHINE SULFATE PRESERVATIVE FREE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136535 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |