FDA Adverse Event
Malfunction
Summary report: N
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
MDR report key: 17516799
·
Received August 11, 2023
Report
- Report Number
- MW5123748
- Event Type
- Malfunction
- Date Received
- August 11, 2023
- Date of Event
- May 2, 2011
- Report Date
- June 3, 2011
- Manufacturer
- MEDTRONIC
- Product Code
- LWS
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
ON 05/02/2011 RECEIVED INFORMATION DR.(B)(6) INTERROGATED DEVICE AND GOT WARNING OF HIGH IMPEDANCE.(B)(6). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2181916 | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | MEDTRONIC | 6944 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |