FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2210326
·
Received August 9, 2011
Report
- Report Number
- 3004209178-2011-06193
- Event Type
- Injury
- Date Received
- August 9, 2011
- Date of Event
- July 19, 2011
- Report Date
- July 19, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- 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
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND THAT THE PUMP HAD TO BE REPLACED. THE DRUG USED 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 | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT # L55565 |