FDA Adverse Event
Malfunction
Summary report: N
CAPSURE SP
MDR report key: 2812766
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-15957
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- September 13, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P830061/S12
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, 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 WHEN THE RIGHT VENTRICULAR LEAD WAS BEING TESTED IN A BIPOLAR PACING CONFIGURATION, THE IMPEDANCE WAS LOW AND AN OUT OF RANGE IMPEDANCE MESSAGE WAS DISPLAYED ON THE PROGRAMMER. 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 |
|---|---|---|---|---|---|---|---|
| 1 | CAPSURE SP | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4024 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | 2002L COMPETITOR IMPLANTABLE PULSE GENERATOR |