FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2062423
·
Received April 12, 2011
Report
- Report Number
- 3004209178-2011-02766
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Date of Event
- March 4, 2011
- Report Date
- March 30, 2011
- 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).
Description of Event or Problem · 1
THE PT PRESENTED FOR A REFILL ON (B)(6) 2011. THERE WAS "ALMOST 18-19 CC IN HER PUMP." A CATHETER DYE STUDY WAS ATTEMPTED ON (B)(6) 2011. THE HCP COULD NOT ACCESS THE CATHETER. THE PT WAS REFERRED TO A SURGEON; IT WAS UNK BY THE REPORTER IF SURGERY WAS SCHEDULED. 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 | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N185651016| ACCESSORY: MODEL 8590-1, LOT# N186319 |