FDA Adverse Event
Malfunction
Summary report: N
EVERA XT DR
MDR report key: 5272575
·
Received December 7, 2015
Report
- Report Number
- 3004209178-2015-23937
- Event Type
- Malfunction
- Date Received
- December 7, 2015
- Report Date
- February 19, 2015
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LWS
- PMA / PMN Number
- P980016
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED AND ANALYZED. A CHARGE TIME OUT FAILURE OCCURRED. FRACTURED LASER RIBBON BONDS (LRB) WERE OBSERVED ON THE HYBRID. THE OPEN LRB WERE THE CAUSE WERE THE CAUSE FOR THE CHARGE TIME OUT FAILURE. THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)ׁS RETURNED TO THE MANUFACTURER AND TESTED OUT OF SPECIFICATION DURING ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 800236 | EVERA XT DR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC PUERTO RICO OPERATIONS CO. | DDBB1D1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00081 YR |