FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE PACEMAKER PULSE-GENERATOR
MDR report key: 17531267
·
Received August 12, 2023
Report
- Report Number
- MW5138182
- Event Type
- Injury
- Date Received
- August 12, 2023
- Report Date
- February 1, 2018
- Manufacturer
- MEDTRONIC
- Product Code
- DXY
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
BOSTON SCIENTIFIC NEUROMODULATION (BSN) RECEIVED INFORMATION ABOUT AN EVENT ON (B)(6) 2016 THAT WOULD HAVE BEEN REPORTABLE UNDER 21 CFR 803, MEDICAL DEVICE REPORTING WITHIN OUR COMPLAINT SYSTEM. THE INFORMATION RECEIVED STATED THAT THE PATIENT'S MEDTRONIC' S IPG WAS EXPLANTED DUE TO DEPLETION. A SECOND EVENT OCCURRED ON (B)(6) 2017 IN WHICH TWO MEDTRONIC EXTENSIONS WERE EXPLANTED DUE TO AN INFECTION. (B)(4). 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 |
|---|---|---|---|---|---|---|---|
| 940193 | IMPLANTABLE PACEMAKER PULSE-GENERATOR | IMPLANTABLE PACEMAKER PULSE-GENERATOR | DXY | MEDTRONIC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |