FDA Adverse Event
Malfunction
Summary report: N
CAPSURE SP NOVUS
MDR report key: 3993839
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09098
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- May 25, 2014
- Report Date
- May 25, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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. CONCOMITANT: 5092-52 LEAD IMPLANTED: 2000-(B)(6), 305C21 TISSUE VALVE IMPLANTED: 2005-(B)(6), (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING. THERE ARE SMALL P-WAVES, BUT THEY ARE CHRONIC PER THE TREND. 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 |
|---|---|---|---|---|---|---|---|
| 469806 | CAPSURE SP NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4592-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00086 YR | SEDR01 IPG |