FDA Adverse Event
Malfunction
Summary report: N
CAPSURE SP 4024
MDR report key: 2951749
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00213
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Report Date
- November 5, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061/S12
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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: ADDR01 IMPLANTABLE PULSE GENERATOR (IPG) (B)(6) 2007. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A WARNING FOR LOW IMPEDANCE THAT HAS STEADILY DECLINING OVER THE PAST YEAR ON THE RIGHT VENTRICULAR (RV) LEAD. THERE HAS ALSO BEEN A SLIGHT INCREASE IN THE RV LEAD THRESHOLD. THE LEAD WAS 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 |
|---|---|---|---|---|---|---|---|
| 56665 | CAPSURE SP 4024 | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4024-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00088 YR | Hospitalization| R | 4524 IMPLANTABLE PACING LEAD |