FDA Adverse Event
Injury
Summary report: N
ELECTRODE, PACEMAKER, PERMANENT
MDR report key: 2952943
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00768
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- November 27, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, 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 COMPLAINED OF CHEST DISCOMFORT AND DIZZINESS. IT WAS FOUND THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD INCREASED BIPOLAR IMPEDANCE TO A HIGH MEASUREMENT. THRESHOLD HAS ALSO INCREASED. THE RV LEAD WAS CAPPED AND REPLACED. DURING THE REPLACEMENT PROCEDURE, IT WAS NOTED THAT THE IMPEDANCE WAS LOW. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 57432 | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4092-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00080 YR | Hospitalization| R | (B)(4) IMPLANTABLE IMPLANTABLE PULSE GENERATOR ( |