FDA Adverse Event
Injury
Summary report: N
CAPSURE SP NOVUS
MDR report key: 1990209
·
Received February 15, 2011
Report
- Report Number
- 2649622-2011-01883
- Event Type
- Injury
- Date Received
- February 15, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P830061/S27
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 RIGHT ATRIAL LEAD WARNING. THE LEAD HAD LOW IMPEDANCE MEASUREMENTS IN BIPOLAR. AT INTERROGATION, THE BIPOLAR IMPEDANCE WAS LOW, AND LOWER THAN THE UNIPOLAR IMPEDANCE; THERE WAS NO CAPTURE OR SENSING IN EITHER POLARITY. THE PATIENT EXPERIENCED POCKET STIMULATION WHEN THE DEVICE WAS PROGRAMMED TO UNIPOLAR PACING. THE LEAD WILL BE REPLACED. THERE HAVE BEEN NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSURE SP NOVUS | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4592 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization| R | 4092 IMPLANTABLE PACING LEAD| E2DR01 IMPLANTABLE PULSE GENERATOR |