FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2172375
·
Received June 23, 2011
Report
- Report Number
- 3004209178-2011-04778
- Event Type
- Malfunction
- Date Received
- June 23, 2011
- Report Date
- May 31, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD CATHETER BREAK IN THE PAST POSSIBLY DUE TO TRAY ON WHEELCHAIR. THE MOST RECENT PUMP IMPLANTED WAS REFILLED WITH BACLOFEN (LIORESAL). NO SYMPTOMS OR PT INJURY HAS BEEN REPORTED REGARDING THE CURRENT IMPLANT. ADDITIONAL INFO 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 |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | IMPLANTED:| CATHETER: MODEL 8709, LOT# L60852| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT# UNK| EXPLANTED:| EXPLANTED:| IMPLANTED:| LOT# NGF040281R| IMPLANTABLE INFUSION PUMP: MODEL 8627-18 |