FDA Adverse Event
Malfunction
Summary report: N
MARATHON DR
MDR report key: 105808
·
Received July 10, 1997
Report
- Report Number
- 1640319-1997-00607
- Event Type
- Malfunction
- Date Received
- July 10, 1997
- Date of Event
- June 1, 1997
- Report Date
- June 12, 1997
- Manufacturer
- SULZER INTERMEDICS INC.
- Product Code
- DXY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE REPORTER INDICATED THAT APPROXIMATELY TWO WEEKS AGO, THE SYSTEM WAS IMPLANTED FOLLOWING EXTRACTION OF TELECTRONIC LEADS. AT THE FOLLOWUP TODAY, OCCASIONAL ATRIAL UNDERSENSING WAS OBSERVED. FOLLOWING THE NON-SENSED P-WAVE, A AND V SPIKES WERE SEEN, WITH THE ATRIAL SPIKE LOOKING "UNIPOLAR (LARGE)" AND THE VENTRICULAR SPIKE LOOKING "BIPOLAR" ON THE RX5000 ECG. THE PATIENT REPORTED PECTORAL MUSCLE STIMULATION AND SEVERE DISTRESS WHEN THIS OCCURRED. FURTHER EVENT DESCRIPTION IS ON PAGE 3 OF THIS FORM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MARATHON DR Implant | IMPLANTABLE PACEMAKER | DXY | SULZER INTERMEDICS INC. | 294-09 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |