FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3023063
·
Received March 27, 2013
Report
- Report Number
- 3004209178-2013-04288
- Event Type
- Injury
- Date Received
- March 27, 2013
- Report Date
- February 27, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 8709SC, LOT# N187816011, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT ID: 8709SC, LOT# N187816011, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THIS PATIENT WAS BEING FURTHER EVALUATED FOR A POSSIBLE TIP GRANULOMA. NO PATIENT SYMPTOMS WERE PROVIDED. IT WAS NOT KNOWN WHAT MEDICATION THIS DEVICE SYSTEM DELIVERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 126278 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |