FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1864480
·
Received October 6, 2010
Report
- Report Number
- 3004209178-2010-07663
- Event Type
- Injury
- Date Received
- October 6, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 9, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4): ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP WAS NOT WORKING EFFICIENTLY. THE ROTOR ONLY TURNED ABOUT 15 DEGREES DURING A ROTOR STUDY INSTEAD OF THE EXPECTED 60 DEGREES. THE PUMP WAS EXPLANTED AND SENT BACK FOR ANALYSIS. ADD'L 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 | 51 YR | Required Intervention | IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N259166007| EXPLANTED:| LOT# NGV442086H| IMPLANTABLE INFUSION PUMP: MODEL 8637-40,| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8711, LOT# L78413| IMPLANTED: |