FDA Adverse Event
Malfunction
Summary report: N
IMPLANTABLE PACEMAKER PULSE-GENERATOR
MDR report key: 17532077
·
Received August 12, 2023
Report
- Report Number
- MW5138986
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- December 1, 2020
- Manufacturer
- BIOTRONIK
- Product Code
- DXY
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
DURING DEVICE FOLLOW-UP THE PHYSICIAN NOTICED PROBLEMS WITH IMPLANTED LEADS. THE PHYSICIAN SUSPECTS LEADS FRACTURE (ATRIAL LEAD: BIOTRONIK 53 JT (B)(4), IMPLANTED: (B)(6) 2003. VENTRICULAR LEAD: BIOTRONIK 60ST (B)(4), IMPLANTED: (B)(6) 2003). (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 |
|---|---|---|---|---|---|---|---|
| 784769 | IMPLANTABLE PACEMAKER PULSE-GENERATOR | IMPLANTABLE PACEMAKER PULSE-GENERATOR | DXY | BIOTRONIK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |