FDA Adverse Event
Malfunction
Summary report: N
VIRTUOSO
MDR report key: 4161698
·
Received October 10, 2014
Report
- Report Number
- 3004209178-2014-19016
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- July 7, 2014
- Report Date
- July 7, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LWS
- PMA / PMN Number
- P980016
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
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. CONCOMITANT PRODUCT: 4271 BOSTON SCIENTIFIC LEAD, IMPLANTED: (B)(6) 1999. (B)(4).
Description of Event or Problem · 1
THE PATIENT REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ALERTS WERE INAUDIBLE. FOLLOW UP WITH THE PATIENT'S CLINIC WAS UNSUCCESSFUL. THE DEVICE REMAINS IN USE AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 640528 | VIRTUOSO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D154AWG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00069 YR | 694958 LEAD |