FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX LEAD
MDR report key: 8898632
·
Received August 15, 2019
Report
- Report Number
- 2649622-2019-14426
- Event Type
- Malfunction
- Date Received
- August 15, 2019
- Date of Event
- July 26, 2019
- Report Date
- August 15, 2019
- Manufacturer
- MPRI
- Product Code
- DTB
- UDI-DI
- 00613994776853
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- NURSE
Narratives
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 THERE WAS A HIGH ATRIAL TACHYCARDIA / ATRIAL FIBRILLATION (AT/AF) COUNTER DUE TO INTERMITTENT FAR FIELD R-WAVE (F FRW). FOLLOW UP CONCLUDED NO INTERVENTION. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 693396 | CAPSUREFIX LEAD | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5568-53 | 00613994776853 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | DTBB1QQ CRT-D, 6947M62 LEAD, 429878 LEAD |