FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2061798
·
Received March 30, 2011
Report
- Report Number
- 3007566237-2011-02418
- Event Type
- Malfunction
- Date Received
- March 30, 2011
- Report Date
- March 21, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD RECURRING CATHETER PROBLEMS. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS BACLOFEN. ADDITIONAL INFO HAS BEEN REQUESTED. 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 NEUROMODULATION | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | CATHETER: MODEL 8709, LOT # J12123R15.| CATHETER: MODEL 8711, LOT # N080793019.| EXPLANTED:| EXPLATNED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8711, LOT # N080793019| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT # J12123R15| EXPLATNED: |