FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3991886
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-10097
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- October 21, 2013
- Report Date
- October 21, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, 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: MODEL: 694765, LEAD; IMPLANT: 2002-(B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENTS RIGHT ATRIAL (RA) LEAD WAS EXHIBITING NOISE. PHYSICIAN CHOSE TO REPLACE THE LEAD AT THE SAME TIME AS CHANGING OUT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR(ERI). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 468738 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00076 YR | Required Intervention | D154AWG, ICD |