FDA Adverse Event
Malfunction
Summary report: N
CAPSURE SENSE LEAD MRI SURESCAN
MDR report key: 9646328
·
Received January 30, 2020
Report
- Report Number
- 2649622-2020-02375
- Event Type
- Malfunction
- Date Received
- January 30, 2020
- Date of Event
- January 20, 2020
- Report Date
- March 2, 2020
- Manufacturer
- MPRI
- Product Code
- DTB
- UDI-DI
- 00643169410916
- PMA / PMN Number
- P830061
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT THE PHYSICIAN COULD NOT GET THE PREFORMED "J" TO CURL UP INSIDE THE RIGHT ATRIUM AS A RESULT OF PLACEMENT DIFFICULTY. THE RA LEAD WAS REMOVED 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 |
|---|---|---|---|---|---|---|---|
| 110176 | CAPSURE SENSE LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 457445 | 00643169410916 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR |