FDA Adverse Event
Injury
Summary report: N
CAPSURE SP 4024
MDR report key: 2954701
·
Received February 11, 2013
Report
- Report Number
- 2649622-2013-01519
- Event Type
- Injury
- Date Received
- February 11, 2013
- Report Date
- December 5, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE 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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD LOW IMPEDANCE AND A LEAD WARNING WAS TRIGGERED. IT WAS NOTED THAT THE PATIENT WAS SYMPTOMATIC WHEN THE UNIPOLAR PACING CONFIGURATION WAS USED. THE LEAD WAS 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 |
|---|---|---|---|---|---|---|---|
| 58880 | CAPSURE SP 4024 | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4024-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00054 YR | Hospitalization| R | (B)(4) |