FDA Adverse Event
Malfunction
Summary report: N
SIGMA 300 DR
MDR report key: 2791752
·
Received October 15, 2012
Report
- Report Number
- 6000144-2012-05449
- Event Type
- Malfunction
- Date Received
- October 15, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P980035/S2
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR AN UNKNOWN REASON AND A PACEMAKER CHECK SHOWED EVIDENCE OF VENTRICULAR SAFETY PACING (VSP) AS THERE WERE OBSERVATIONS OF PACEMAKER SPIKES IN THE QRS. THE CAUSE OF THE VSP COULD NOT BE DETERMINED AND ONCE THE PATIENT'S METABOLIC STATUS STABILIZED IT RESOLVED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIGMA 300 DR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | SDR303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Other | 5092 IMPLANTABLE PACING LEAD| 4592 IMPLANTABLE PACING LEAD |