FDA Adverse Event
Injury
Summary report: N
ELECTRODE, PACEMAKER, PERMANENT
MDR report key: 3153209
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05872
- Event Type
- Injury
- Date Received
- June 8, 2013
- Report Date
- April 5, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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 PRODUCTS: 4024 IMPLANTABLE PACING LEAD (B)(6) 2001; ADDR01 IMPLANTABLE PULSE GENERATOR (IPG) (B)(6) 2011. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT BOTH THE RIGHT VENTRICULAR (RV) LEAD AND THE RIGHT ATRIAL (RA) LEAD HAD DECREASED TO LOW IMPEDANCE. THE RV LEAD ALSO HAD OVERSENSING. BOTH LEADS WERE 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 |
|---|---|---|---|---|---|---|---|
| 256054 | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4524 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |