FDA Adverse Event
Malfunction
Summary report: N
SELOX SR 60
MDR report key: 2532996
·
Received April 9, 2012
Report
- Report Number
- 1028232-2012-00792
- Event Type
- Malfunction
- Date Received
- April 9, 2012
- Date of Event
- February 27, 2012
- Report Date
- March 26, 2012
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- DTB
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4) MDR.
Description of Event or Problem · 1
(B)(4) MDR - THE PT COMPLAINED OF CHEST PAIN. VENTRICULAR OVERSENSING AND 19 VENTRICULAR PAUSES WERE FOUND IN THE HOLTER. DURING THE FOLLOW-UP, THE LEAD POLARITY HAD BEEN CHANGED TO UNIPOLAR WITH THE THRESHOLD OF 2 .5V/0.4MS AND THE SENSING AMPLITUDE OF 2.5-3, OMV. AN X-RAY WAS PERFORMED AND A LEAD FRACTURE COULD BE SEEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SELOX SR 60 | PACEMAKER | DTB | BIOTRONIK SE & CO. KG | 343082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |