FDA Adverse Event
Injury
Summary report: N
CAPSURE SP 4024
MDR report key: 2955461
·
Received February 11, 2013
Report
- Report Number
- 2649622-2013-01412
- Event Type
- Injury
- Date Received
- February 11, 2013
- Report Date
- December 4, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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. CONCOMITANT PRODUCT: 4068 IMPLANTABLE PACING LEAD (B)(6) 1998. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD HAD LOW IMPEDANCE. THE LEADS WERE REPROGRAMMED AND LATER CAPPED AND REPLACED AT THE TIME OF THE IMPLANTABLE PULSE GENERATOR (IPG) CHANGE DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59555 | CAPSURE SP 4024 | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4024-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | 7960IB IMPLANTABLE PULSE GENERATOR |