FDA Adverse Event
Injury
Summary report: N
CAPSURE SP
MDR report key: 3062196
·
Received April 16, 2013
Report
- Report Number
- 2649622-2013-05119
- Event Type
- Injury
- Date Received
- April 16, 2013
- Report Date
- February 26, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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. DEVICE: 4524 IMPLANTABLE PACING LEAD (B)(6) 1998; VEDR01 IMPLANTABLE PULSE GENERATOR (B)(6) 2007. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS LEAD WARNINGS FOR THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS HAVING LOW/OUT OF RANGE IMPEDANCE. THE RA LEAD ALSO HAD LOWER BIPOLAR THAN UNIPOLAR IMPEDANCES. THE RA AND RV LEADS WERE CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 162344 | CAPSURE SP | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4024-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00079 YR | Hospitalization| R |