FDA Adverse Event
Malfunction
Summary report: N
ELAPASSP758
MDR report key: 22556339
·
Received July 21, 2025
Report
- Report Number
- MW5173025
- Event Type
- Malfunction
- Date Received
- July 21, 2025
- Date of Event
- June 4, 2025
- Report Date
- August 8, 2025
- Manufacturer
- ELA MEDICAL/MICROPORT CRM USA INC.
- Product Code
- DTB
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
IT WAS REPORTED IN A PRE-PROCEDURE DIAGNOSIS DOCUMENT THAT THE PACEMAKER LEAD EXHIBITED A MALFUNCTION. THE SPECIFIC LEAD AND ANOMALY WERE NOT STATED. PATIENT CODE: 4582. DEVICE CODE: 2588. REFERENCE REPORT #MW5173024. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".
Description of Event or Problem · 0
ADDITIONAL INFORMATION RECEIVED ON 08/08/2025 FOR A REPORT #MW5173025 TO CHANGE THE MANUFACTURER. IT WAS REPORTED IN A PRE-PROCEDURE DIAGNOSIS DOCUMENT THAT THE PACEMAKER LEAD EXHIBITED A MALFUNCTION. THE SPECIFIC LEAD AND ANOMALY WERE NOT STATED. PATIENT CODE: 4582. DEVICE CODE: 2588. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REFERENCE REPORT: #MW5173024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 802991 | ELAPASSP758 | PERMANENT PACEMAKER ELECTRODE | DTB | ELA MEDICAL/MICROPORT CRM USA INC. | ELAPASSP758 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |