FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIXNOVUS
MDR report key: 3153466
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-06025
- Event Type
- Malfunction
- Date Received
- June 8, 2013
- Report Date
- March 28, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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: ADDRL1 IMPLANTABLE PULSE GENERATOR (B)(6) 2008. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD DISPLAYED NOISE ON ELECTROCARDIOGRAM (ECG). THE PATIENT WILL WEAR A HOLTER MONITOR AND THE RESULTS WILL DETERMINE IF FURTHER ACTION IS REQUIRED. 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 |
|---|---|---|---|---|---|---|---|
| 258822 | CAPSUREFIXNOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00087 YR | 5076 IMPLANTABLE PACING LEAD |