FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 4243896
·
Received November 11, 2014
Report
- Report Number
- 3004209178-2014-21345
- Event Type
- Injury
- Date Received
- November 11, 2014
- Report Date
- October 21, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8784, SERIAL# (B)(4) IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT MAY HAVE HAD 1 TO 2 REVISIONS PRIOR. IT WAS UNKNOWN WHAT THE PUMP WAS INFUSING. NO REASON FOR THE INTERVENTIONS, PUMP MEDICATION, OR OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN MORE INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 725053 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |