FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3032827
·
Received April 3, 2013
Report
- Report Number
- 3004209178-2013-04529
- Event Type
- Injury
- Date Received
- April 3, 2013
- Report Date
- March 5, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THIS PUMP "KEPT TURNING" AND THE PHYSICIAN HAD A DIFFICULT TIME GETTING THE NEEDLE IN THE PUMP. NO OTHER PROBLEMS WERE NOTED AND THE PUMP WAS REPORTED TO HAVE BEEN REPLACED DUE TO THE BATTERY. IT WAS NOT KNOWN WHAT MEDICATION THIS DEVICE SYSTEM DELIVERED AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Description of Event or Problem · 1
IT WAS LATER REPORTED THE HCP DID NOT HAVE ANY ISSUES FILLING THE PUMP. THE PUMP WAS SECURE AND HAD NOT FLIPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136152 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |