FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2063764
·
Received April 14, 2011
Report
- Report Number
- 3004209178-2011-02813
- Event Type
- Injury
- Date Received
- April 14, 2011
- Date of Event
- March 25, 2011
- Report Date
- April 1, 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
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
AN 'IDIOPATHIC" (B)(4) CATHETER FRACTURE WAS REPORTED. THE PT EXPERIENCED NO ADVERSE REACTION TO THE FRACTURE. THE CATHETER FRACTURED DISTAL TO THE CONNECTION BETWEEN THE PROXIMAL AND DISTAL SEGMENTS. THE CATHETER WAS REPAIRED ON (B)(6) 2011 AND REPLACED WITH AN (B)(4) CATHETER. THE PT'S OUTCOME WAS NOT REPORTED. 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 | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Required Intervention | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8711, LOT# N098642005 |