FDA Adverse Event
Injury
Summary report: N
MYOCARDIAL LEAD
MDR report key: 4162680
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-12647
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- July 31, 2014
- Report Date
- July 31, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- PRE-AMEND
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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: ADDR06 IPG, IMPLANTED: (B)(6) 2007. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS EXHIBITING HIGH IMPEDANCE DUE TO FRACTURE. THE 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 |
|---|---|---|---|---|---|---|---|
| 643134 | MYOCARDIAL LEAD | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 6917-35T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00041 YR | Hospitalization| R | 10295A50 LEAD |