CAPSUREFIX LEAD
Report
- Report Number
- 2649622-2022-03041
- Event Type
- Injury
- Date Received
- February 12, 2022
- Date of Event
- November 2, 2021
- Report Date
- February 12, 2022
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: W1DR01 IPG, IMPLANTED: (B)(6) 2021. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: W1DR01 IPG, IMPLANTED: (B)(6) 2021. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT FIVE DAYS POST IMPLANTABLE PULSE GENERATOR (IPG) GENERATOR CHANGE THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND NO CAPTURE. THE RA LEAD WAS CAPPED AND REPLACED. IT WAS FURTHER REPORTED THAT DURING THE RA LEAD REPLACEMENT THE RIGHT VENTRICULAR (RV) LEAD INSULATION BECAME DAMAGED. THE RV LEAD WAS THEN CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT FIVE DAYS POST IMPLANTABLE PULSE GENERATOR (IPG) GENERATOR CHANGE THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND NO CAPTURE. THE RA LEAD WAS CAPPED AND REPLACED. IT WAS FURTHER REPORTED THAT DURING THE RA LEAD REPLACEMENT THE RIGHT VENTRICULAR (RV) LEAD INSULATION BECAME DAMAGED. THE RV LEAD WAS THEN CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110286 | CAPSUREFIX LEAD | PERMANENT PACEMAKER ELECTRODE | DTB | MPRI | 506852 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Female | Hospitalization| R | 5054-58 LEAD |