FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1842086
·
Received September 20, 2010
Report
- Report Number
- 3004209178-2010-07104
- Event Type
- Injury
- Date Received
- September 20, 2010
- Date of Event
- August 20, 2009
- Report Date
- August 20, 2009
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- 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 FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP AND CATHETER WERE REMOVED DUE TO INFECTION. THE DEVICE WAS NOT REPLACED. THERE WAS NO PT INJURY AND THE PT RECOVERED WITHOUT SEQUELA. THE HOSPITAL RECENTLY GAVE THE PUMP TO THE COMPANY REP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention | CATHETER: MODEL 8709SC, LOT# N208061012| IMPLANTED:| EXPLANTED: |