FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2883692
·
Received December 21, 2012
Report
- Report Number
- 3004209178-2012-12164
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- November 20, 2012
- Report Date
- November 21, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8703W, LOT # L62221, IMPLANTED: (B)(6) 1999, PRODUCT TYPE CATHETER; PRODUCT ID 8551, LOT # CS0532, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS AN ISSUE AS THE PATIENT'S "PUMP HAD RAN DRY" YESTERDAY (B)(6) 2012. IT WAS INDICATED THAT THE PATIENT WAS VERY PLEASED WITH THE PUMP. THE OUTCOME OF THE PATIENT WAS NOT PROVIDED. THE DRUGS DELIVERED VIA PUMP WERE FENTANYL, BACLOFEN, AND BUPIVACAINE. ADDITIONAL INFORMATION HAD BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR |