FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1032905
·
Received April 23, 2008
Report
- Report Number
- 2182207-2008-02164
- Event Type
- Malfunction
- Date Received
- April 23, 2008
- Date of Event
- March 20, 2008
- Report Date
- March 25, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN MRI PROCEDURE, THE PUMP MOTOR STALLED. THE 48 HR TUBE SET ERROR MESSAGE WAS RECORDED IN THE PUMP LOGS IN 2008, AT 9:25 A.M. THE PUMP MOTOR STALL RECOVERED AFTER THE PUMP WAS INTERROGATED THREE DAYS LATER. THE PT EXPERIENCED INCREASED PAIN RELATED TO THE EVENT. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADD'L 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 | 83 YR | Required Intervention | PROGRAMMER MODEL 8840 LOT#UNK| EXPLANTED| CATHETER MODEL 8596 LOT # B011725N10| IMPLANTED |