FDA Adverse Event
Injury
Summary report: N
ACCENT DR RF
MDR report key: 3920527
·
Received July 8, 2014
Report
- Report Number
- 2017865-2014-14128
- Event Type
- Injury
- Date Received
- July 8, 2014
- Date of Event
- May 6, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- Z0429
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS FOUND NORMAL DEVICE CHARACTERISTICS.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FEELING DIZZY AND A SURFACE ELECTROGRAM SHOWED BRADYCARDIA. UPON INTERROGATION, THE RIGHT VENTRICULAR LEAD EXHIBITED OVERSENSING OF NOISE, WHICH CAUSED PACING INHIBITION. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 396307 | ACCENT DR RF | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL, INC., CRMD | PM2210 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |