FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3033363
·
Received April 3, 2013
Report
- Report Number
- 3004209178-2013-04555
- Event Type
- Injury
- Date Received
- April 3, 2013
- Report Date
- March 5, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 8703W LOT# L36996, IMPLANTED: 1995 (B)(6), PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT HAD WOUND DEHISCENCE AND EROSION OF THE POCKET SITE AND THE PUMP AND CATHETER WERE REMOVED. IT WAS NOTED THAT A FENTANYL PATCH WAS USED INSTEAD OF THE PUMP. A RE-IMPLANT WAS SCHEDULED FOR (B)(6) 2013. THE EXPLANTED COMPONENTS WILL NOT BE RETURNED AS THEY WERE DISCARDED. THE PATIENT OUTCOME WAS REPORTED AS ALIVE - NO INJURY/NO ADVERSE EVENT. THE PUMP SYSTEM WAS BEING USED TO DELIVER DILAUDID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 137001 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00051 YR | Required Intervention |