FDA Adverse Event
Injury
Summary report: N
TRANSVENOUS LEAD
MDR report key: 3990519
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-08602
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- May 2, 2014
- Report Date
- May 2, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- K940703
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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 MEDICAL PRODUCTS: E2DR01AA IPG, IMPLANTED: (B)(6) 2006. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WERE HIGH THRESHOLDS AND LOW IMPEDANCE ON THE RV (RIGHT VENTRICULAR) LEAD, ALONG WITH NO CAPTURE ON THE ATRIAL LEAD. 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 |
|---|---|---|---|---|---|---|---|
| 468577 | TRANSVENOUS LEAD | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4558M-53 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00074 YR | Hospitalization| R | 4024-58 LEAD |