FDA Adverse Event
Injury
Summary report: N
EPIC PLUS DR
MDR report key: 1954718
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00568
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- October 14, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. OTHER TEXT : DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN
Additional Manufacturer Narrative · 1
REPORTED NOISE COMPLAINT WAS CONFIRMED AFTER REVIEW OF EGMS. DEVICE UNDERWENT BENCH AND ATE TESTING. NO ANOMALY FOUND AS REAL-TIME EGM WAS NOISE-FREE. THE CAUSE OF NOISE OBSERVED IN THE FIELD COULD NOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING FOLLOW-UP VISIT, ONE ABORTED VF EPISODE WAS NOTED. NOISE WAS NOTED ON THE VENTRICULAR AND ATRIAL LEADS. THE PHYSICIAN SUSPECTS A HEADER ISSUE. THE DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EPIC PLUS DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-239 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention | (B)(4) |