FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1972392
·
Received January 20, 2011
Report
- Report Number
- 3004209178-2011-00517
- Event Type
- Injury
- Date Received
- January 20, 2011
- Date of Event
- January 7, 2011
- Report Date
- January 14, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED LATER INDICATED THAT THE HIGH LEVEL OF CRP (C-REACTIVE PROTEIN INDICATED AS 6.49 IN PREVIOUS REPORT) WAS BELIEVED TO BE CAUSED BY INFECTION, "NOT RELATED TO INVESTIGATION DRUG OR DEVICES". PATIENT WAS NOTED AS RECOVERING FROM FEVER ON (B)(6) 2011.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FEVER OF 38 DEGREES C (CENTIGRADE) SINCE (B)(6) 2011. THE HCP INDICATED THAT IT WAS LIKELY DUE TO INFECTION BASED ON THE CRP LEVEL. A FOLLOW-UP REPORT WILL BE SENT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00063 YR | Required Intervention | CATHETER: MODEL 8711, LOT# N160635031| IMPLANTED:| EXPLANTED: |