FDA Adverse Event
Injury
Summary report: N
MYOCARDIAL LEAD
MDR report key: 3993046
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09534
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- June 20, 2014
- Report Date
- June 20, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- K031274
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NURSE
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. PRODUCTS: 5071-35 LEAD IMPLANTED: 2013 (B)(6); 4968-35 LEAD 2013 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TWO RIGHT VENTRICULAR (RV) EPICARDIAL LEADS THAT WERE ADAPTED TOGETHER AND WERE OVERSENSING T WAVES. THE LEADS WERE REPROGRAMMED AND REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 472787 | MYOCARDIAL LEAD | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5071-35 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00072 YR | Required Intervention | ADDRL1 IPG |