FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2950001
·
Received February 8, 2013
Report
- Report Number
- 3004209178-2013-01468
- Event Type
- Injury
- Date Received
- February 8, 2013
- Report Date
- January 22, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER. (B)(4). ANALYSIS OF THE CATHETER FOUND ONLY THE CATHETER WAS RETURNED IN SEGMENTS AND ONLY THE DISTAL PORTION WAS RETURNED. NO ANOMALIES WERE NOTED WITH THE SEGMENT.
Description of Event or Problem · 1
IT WAS REPORTED THE CATHETER WAS EXPLANTED BECAUSE THE PATIENT DID NOT RESPOND TO DRUG INFUSION. NO PATIENT INJURY WAS REPORTED. 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 |
|---|---|---|---|---|---|---|---|
| 54642 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00008 YR | Required Intervention |