FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX
MDR report key: 2954318
·
Received February 11, 2013
Report
- Report Number
- 2649622-2013-02216
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Report Date
- October 24, 2012
- Manufacturer
- MPRI
- Product Code
- NVN
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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 CONTINUED: (B)(4) IMPLANTABLE PACING LEAD (B)(6) 2001. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS UNABLE TO CAPTURE IN BIPOLAR CONFIGURATION AND THE BIPOLAR IMPEDANCE WAS LOW. THE LEAD WAS ASSUMED TO HAVE AN OUTER INSULATION BREAK. HOWEVER, THE RV LEAD WAS FUNCTIONAL IN UNIPOLAR POLARITY THEREFORE THE LEAD WAS RETAINED AND REMAINS IN USE IN THE UNIPOLAR CONFIGURATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58698 | CAPSUREFIX | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | MPRI | 4068-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00095 YR | Hospitalization| R | (B)(4) IMPLANTABLE PULSE GENERATOR |