FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1864489
·
Received October 6, 2010
Report
- Report Number
- 3004209178-2010-07652
- Event Type
- Injury
- Date Received
- October 6, 2010
- Date of Event
- August 1, 2010
- Report Date
- August 18, 2010
- 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
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE ACCESSORY MODEL #8578 WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ACCESSORY KIT WAS USED TO ANCHOR CATHETER AND COMBINE TWO PIECES OF CATHETER. THE ACCESSORY WAS REMOVED FOR UNKNOWN REASONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention | IMPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J11027R58| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8578, LOT# N252331009| EXPLANTED:| CATHETER: MODEL 8598A, LOT# N219336013 |