FDA Adverse Event
Injury
Summary report: N
CAPSURE SP 4024
MDR report key: 3153066
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05799
- Event Type
- Injury
- Date Received
- June 8, 2013
- Report Date
- March 7, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, 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 DURING A ROUTINE DEVICE CHANGE, IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD WAS GREATER UNIPOLAR THAN BIPOLAR. TREND DATA INDICATED THAT THE IMPEDANCE HAD DIMINISHED OVER TIME TO LOW IMPEDANCE IN BOTH POLARITIES. THE RV 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 |
|---|---|---|---|---|---|---|---|
| 256162 | CAPSURE SP 4024 | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4024-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00069 YR | Hospitalization| R |