FDA Adverse Event
Injury
Summary report: N
EVERA XT DR
MDR report key: 3740988
·
Received April 10, 2014
Report
- Report Number
- 3004209178-2014-06068
- Event Type
- Injury
- Date Received
- April 10, 2014
- Date of Event
- November 6, 2013
- Report Date
- January 21, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LWS
- PMA / PMN Number
- P980016
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
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. ANALYSIS INFORMATION (B)(6) 2014, 18:28:56, CST PLI# 10, PRODUCT ID: DDBB1D4, THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR HAS HIGH DEFIBRILLATION THRESHOLDS THE DAY AFTER IMPLANTATION. THE ICD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 217447 | EVERA XT DR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | DDBB1D4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00019 YR | Required Intervention | 7122Q COMPETITOR LEAD IMPLANTED (B)(6) 2013 |