FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2093968
·
Received May 16, 2011
Report
- Report Number
- 3004209178-2011-03550
- Event Type
- Injury
- Date Received
- May 16, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 22, 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
- NC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S CURRENT PUMP HAD TO BE ANCHORED DOWN AND CATHETER BROKE. A SECTION OF THE CATHETER WAS NOT ABLE TO BE RECOVERED. THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS NOT KNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED 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 | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other| R | UNK CONVERSION TYPE: MODEL 8590-9, LOT# N238707| EXPLANTED:| IMPLANTED: |