FDA Adverse Event
Injury
Summary report: N
ASSURITY RF DR
MDR report key: 18476286
·
Received January 9, 2024
Report
- Report Number
- 2017865-2024-00753
- Event Type
- Injury
- Date Received
- January 9, 2024
- Date of Event
- December 24, 2023
- Report Date
- February 6, 2024
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NVZ
- UDI-DI
- 05414734507073
- PMA / PMN Number
- P880086
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CORRECTION: G3 IN MDR-2024-01605-01 SHOULD HAVE BEEN JAN 19, 2024 INSTEAD OF JAN 22, 2024.
Description of Event or Problem · 0
FOLLOWING THE ELECTRONICS PERFORMANCE INDICATOR (EPI), AN ALERT WAS RECEIVED BY THE CLINICIAN AND DEVICE WAS EXPLANTED. DEVICE WAS ALSO EXHIBITING INTERMITTENT CAPTURE THAT LED TO PATIENT DIZZINESS, PRE-SYNCOPE, AND LOW HEART RATES. DOCTOR ELECTED TO PLACE A TEMPORARY PACEMAKER WIRE ON (B)(6) 2023 AND THEN DO A FULL DEVICE REPLACEMENT SURGERY ON (B)(6) 2023. PATIENT WAS STABLE FOLLOWING THE REPLACEMENT PROCEDURE.
Description of Event or Problem · 0
NEWLY RECEIVED INFORMATION NOTED PATIENT ALSO EXPERIENCED FATIGUE DUE TO THE PACEMAKER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 462427 | ASSURITY RF DR | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | PM2240 | A000031040 | 05414734507073 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention | 1699TC/46CM OPTISENSE LEAD.| 1888TC/58 LEAD. |