FDA Adverse Event
Injury
Summary report: N
CAPSURE SP
MDR report key: 1990909
·
Received February 15, 2011
Report
- Report Number
- 2649622-2011-02172
- Event Type
- Injury
- Date Received
- February 15, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P830061/S12
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD HAS LOW IMPEDANCE AND THAT UNIPOLAR IMPEDANCE WAS MEASURING HIGHER THAN BIPOLAR. THE LEAD HAS BEEN PROGRAMMED TO UNIPOLAR PACING AND 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. | 4524 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization| R | 4024 IMPLANTABLE PACING LEAD| 7960IB IMPLANTABLE PULSE GENERATOR |