FDA Adverse Event
Injury
Summary report: N
CAPSURE SP
MDR report key: 2952728
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00678
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- November 14, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING POCKET STIMULATION. BOTH THE RIGHT VENTRICULAR (RV) LEAD AND THE RIGHT ATRIAL (RA) LEADS WERE CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56802 | CAPSURE SP | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00060 YR | Hospitalization| R | (B)(4) IMPLANTABLE PULSE GENERATOR |