FDA Adverse Event
Injury
Summary report: N
VIRTUOSO VR
MDR report key: 3160468
·
Received June 10, 2013
Report
- Report Number
- 3004209178-2013-10077
- Event Type
- Injury
- Date Received
- June 10, 2013
- Date of Event
- March 28, 2013
- Report Date
- June 15, 2021
- 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
- DC, 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. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI) EARLY. THE DEVICE WAS REMOVED 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 |
|---|---|---|---|---|---|---|---|
| 259570 | VIRTUOSO VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D154VWC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Hospitalization| R | 6947 IMPLANTABLE TACHY LEAD| 6947 IMPLANTABLE TACHY LEAD |