FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIXNOVUS
MDR report key: 3153632
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-06129
- Event Type
- Malfunction
- Date Received
- June 8, 2013
- Report Date
- March 11, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- PHYSICIAN
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 PRODUCTS: 5076-52 IMPLANTABLE PACING LEAD, (B)(6) 2005. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A REMOTE TRANSMISSION SHOWED NOISE AND OVERSENSING DEVELOPING ON THE RIGHT VENTRICULAR LEAD. THE ATRIAL LEAD ALSO SHOWS NOISE AND FAR FIELD R-WAVE OVERSENSING. BOTH LEADS WILL BE MONITORED AND ARE STILL 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 |
|---|---|---|---|---|---|---|---|
| 254375 | CAPSUREFIXNOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | P1501DR IMPLANTABLE PULSE GENERATOR |