FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1851140
·
Received September 30, 2010
Report
- Report Number
- 3004209178-2010-07448
- Event Type
- Injury
- Date Received
- September 30, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 1, 2010
- 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): ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT DEVELOPED A PUSTULAR INFECTION, DEHISION DATE (B)(6)2010. THE PUMP WAS REMOVED BY GENERAL SURGEON WITH THE COMPANY REP PRESENT. THERE WAS A POCKET INFECTION WITH (B)(6) AND PSEUDOMONAS.
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 | 58 YR | Required Intervention | IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J11461R18 |