FDA Adverse Event
Injury
Summary report: N
MYOCARDIAL LEAD
MDR report key: 4160646
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-11806
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- July 7, 2014
- Report Date
- July 7, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- K031274
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, 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 PRODUCT: 8042B, IPG, IMPLANTED: (B)(6) 2010. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED EARLY ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO HIGH THRESHOLDS ON BOTH THE RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD. THE IPG, RV LEAD, AND LV LEAD WERE EXPLANTED 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 |
|---|---|---|---|---|---|---|---|
| 641320 | MYOCARDIAL LEAD | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5071-53 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00062 YR | Hospitalization| R | 5076-52 LEAD, 5076-45 LEAD |