FDA Adverse Event
Malfunction
Summary report: N
CAPSURE SP 4024
MDR report key: 2953823
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-01326
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Report Date
- December 6, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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 PRODUCTS 4524 IMPLANTABLE PACING LEAD (B)(6) 1995. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE THERE IS THE OBSERVANCE OF NOISE ON THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD. ALL OTHER MEASUREMENTS ARE WITHIN NORMAL LIMITS. BOTH LEADS REMAIN IN USE, AND MAY BE REPLACED AT SOME POINT IN THE FUTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55867 | CAPSURE SP 4024 | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4024-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00065 YR | E2DR01AA IMPLANTABLE PULSE GENERATOR (IPG) |