FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1800088
·
Received August 11, 2010
Report
- Report Number
- 3007566237-2010-06030
- Event Type
- Malfunction
- Date Received
- August 11, 2010
- Date of Event
- January 1, 2010
- Report Date
- July 12, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A MOTOR STALL WITH A PUMP. THIS WAS CONFIRMED IN THE EVENT LOGS WHERE NO MOTOR STALL RECOVERY WAS RECORDED. THE MOST RECENT STALLS WERE REPORTED ON (B)(6)2010 AT 0422 AND (B)(6)2010 AT 0422 WITH NO RECOVERY DATE. PT WAS REPORTED AS DOING "OK." ENVIRONMENTAL CONDITIONS SUCH AS ELECTROMECHANICAL INTERFERENCE WERE RULED OUT AS A CAUSE OF THE MOTOR STALL. 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 | MEDTRONIC NEUROMODULATION | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | EXPLANTED:| CATHETER: MODEL 8709, LOT # N004661426| IMPLANTED: |