FDA Adverse Event
Injury
Summary report: N
SELECTSECURE
MDR report key: 3861436
·
Received June 10, 2014
Report
- Report Number
- 2649622-2014-07287
- Event Type
- Injury
- Date Received
- June 10, 2014
- Date of Event
- April 9, 2013
- Report Date
- April 9, 2014
- Manufacturer
- MPRI
- Product Code
- NVN
- PMA / PMN Number
- P030036
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, 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: ADDR01, IPG, IMPLANTED: (B)(6) 2011. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD HAD HIGH IMPEDANCE. THE ATRIAL LEAD WAS CAPPED AND REPLACED. THE PATIENT WAS A PARTICIPANT IN THE SYSTEM LONGEVITY STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 337373 | SELECTSECURE | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | MPRI | 383059 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00026 YR | Hospitalization| R | 383069, LEAD |