FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2093615
·
Received May 12, 2011
Report
- Report Number
- 3004209178-2011-03476
- Event Type
- Injury
- Date Received
- May 12, 2011
- Report Date
- April 26, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE 40 ML PUMP WAS "TOO BIG AND KEPT COMING THROUGH THE SKIN;" EROSION WAS NOTED. THE PUMP WAS REPLACED WITH A SMALLER, 20 ML PUMP. ADDITIONAL INFO 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 | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention | IMPLANTED:| EXPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 8637-20,| IMPLANTED:| CATHETER: MODEL 8703W, LOT# L36762| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8575, LOT# N074877| EXPLANTED:| LOT# NGP353667H |