FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3153652
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-06146
- Event Type
- Injury
- Date Received
- June 8, 2013
- Report Date
- March 27, 2013
- 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
- NURSE
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. 5076-52 IMPLANTABLE PACING LEAD, (B)(6) 2007. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS FAR-FIELD R-WAVE OVERSENSING (FFRW) NOTED ON A REMOTE MONITORING TRANSMISSION. WHEN THE PATIENT CAME TO THE OFFICE, NO FFRW WAS SEEN. THE POLARITY WAS CHANGED TO UNIPOLAR AND FFRW WAS NOTED. ADDITIONAL NON-PHYSIOLOGIC SENSES AND NOISE WERE ALSO NOTED. SENSITIVITY WAS REPROGRAMMED AND THE ATRIAL 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 |
|---|---|---|---|---|---|---|---|
| 254163 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00061 YR | Hospitalization| R | (B)(4) IMPLANTABLE PULSE GENERATOR |