FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1994343
·
Received January 14, 2011
Report
- Report Number
- 3004209178-2011-00393
- Event Type
- Malfunction
- Date Received
- January 14, 2011
- Date of Event
- January 6, 2011
- Report Date
- January 7, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT FELL DOWN IN THE MORNING. THE NEXT DAY THE PATIENT HAD A CHANGE IN THERAPY EFFECT. THE PATIENT HAD SORENESS/STIFFNESS IN HIS LOW BACK. THE PATIENT WAS CONCERNED THAT THE CATHETER COULD HAVE BEEN PULLED OUT OF PLACE. THE PATIENT WAS AT HOME; HIS STATUS WAS REPORTED TO BE "FAIR". THE PATIENT HAD AN APPOINTMENT SCHEDULED TO SEE HIS PHYSICIAN THE FOLLOWING (B)(6). ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
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 | 69 YR | EXPLANTED:| CATHETER: MODEL 8709, LOT# N089085030| IMPLANTED: |