FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1231166
·
Received November 12, 2008
Report
- Report Number
- 3004209178-2008-07403
- Event Type
- Malfunction
- Date Received
- November 12, 2008
- Date of Event
- October 1, 2008
- Report Date
- October 14, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT AN X-RAY SHOWED THAT THE CATHETER HAD BECOME DISLODGED. (DATE OF THE X-RAY WAS NOT REPORTED) THERE WAS NO KNOWN EVENT THAT CAUSED THIS. THE HEALTH CARE PROFESSIONAL WAS ORDERING A MYELOGRAM. NO PT SYMPTOMS WERE REPORTED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | PROGRAMMER: MODEL 8840| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709 |