FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX
MDR report key: 2811193
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-15838
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A POLARITY SWITCH ON THE ATRIAL LEAD AND LOW IMPEDANCE WAS NOTED. IT WAS ALSO NOTED THAT UNIPOLAR IMPEDANCE WAS HIGHER THAN BIPOLAR. AN INSULATION ISSUE IS SUSPECTED. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSUREFIX | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other | E1DR01 IMPLANTABLE PULSE GENERATOR| 5032 IMPLANTABLE PACING LEAD |