QUICKFLEX MICRO LV LEAD
Report
- Report Number
- 2017865-2022-09188
- Event Type
- Injury
- Date Received
- May 7, 2022
- Date of Event
- April 18, 2022
- Report Date
- June 8, 2022
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- OJX
- UDI-DI
- 05414734502610
- PMA / PMN Number
- P030054
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.
CORRECTION: SECTION D1, D4, D6A, D6B, G3 PMA AND SECTION H4 - THE REPORTED BRAND NAME, MODEL NUMBER, SERIAL NUMBER, LOT NUMBER, EXPIRATION DATE, UDI, DATE OF IMPLANT, DATE OF EXPLANT, PMA NUMBER AND MANUFACTURING DATE SHOULD BE CORRECTED TO D1 - QUICKFLEX MICRO LV LEAD, DEVICE CODE OJX. D4 MODEL NUMBER 1258T/86, SERIAL NUMBER (B)(6), LOT NUMBER A000059780, EXPIRATION DATE 31 MAY 2021, UDI (B)(4). D6A DATE OF IMPLANT (B)(6) 2018. D6B DATE OF EXPLANT (B)(6) 2022. G3 PMA NUMBER P030054. AND H4 DEVICE MANUFACTURE DATE 13 JUN 2018 RESPECTIVELY.
IT WAS REPORTED THAT AN UNSPECIFIED LEAD REVISION TOOK PLACE. THE LEAD WAS REVISED AND REPLACED ON (B)(6) 2022. PATIENT HEALTH CONSEQUENCES WERE UNKNOWN.
NEW INFORMATION RECEIVED NOTED THAT THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2022. THE PATIENT WAS REPORTED TO BE FEELING WELL AND WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1731926 | QUICKFLEX MICRO LV LEAD | PERMANENT PACEMAKER ELECTRODE | OJX | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 1258T/86 | A000059780 | 05414734502610 |
| 2065315 | QUICKFLEX MICRO LV LEAD | PERMANENT PACEMAKER ELECTRODE | OJX | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 1258T/86 | A000059780 | 05414734502610 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |