FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS LEAD MRI SURESCAN
MDR report key: 3993149
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09466
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- April 4, 2014
- Report Date
- March 1, 2021
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCTS: 694765 LEAD 2009 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD DEMONSTRATED ABNORMAL PACING IMPEDANCE VARIATIONS FOR MORE THAN 18 MONTHS AND FINALLY TRIGGERED A HIGH IMPEDANCE ALERT MORE RECENTLY. A CONNECTION ISSUE IS SUSPECTED. THE LEAD REMAINS IN USE AND WILL BE MONITORED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 467238 | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00061 YR | Life Threatening| R | D154AWG ICD| DDBB1D1 ICD| (B)(4) ICD |