FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2143028
·
Received June 23, 2011
Report
- Report Number
- 3004209178-2011-04704
- Event Type
- Injury
- Date Received
- June 23, 2011
- Date of Event
- May 1, 2011
- Report Date
- May 31, 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
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP WAS NOT STAYING STITCHED WHERE IT WAS IMPLANTED. THE PUMP WAS MOVED AND RE-STITCHED. PER THE REPORTER, FOLLOWING THAT PROCEDURE, THE SITE BLED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT PROVIDED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO 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 | 60 YR | Required Intervention | CATHETER: MODEL 8709SC, LOT# N259871006| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8596SC, LOT# N253759003 |