FDA Adverse Event
Injury
Summary report: N
SELECTSECURE
MDR report key: 4160038
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-12054
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- May 6, 2014
- Report Date
- July 7, 2014
- Manufacturer
- MPRI
- Product Code
- NVN
- PMA / PMN Number
- P030036
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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. (B)(4).
Description of Event or Problem · 1
IT WAS FURTHER REPORTED THAT THE LEAD WAS ELECTRICALLY ABANDONED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD HAD HIGH THRESHOLDS AND NO CAPTURE. THE LEAD WAS REPROGRAMMED AND REMAINS IN USE. THE PATIENT IS ENROLLED IN THE PRODUCT SURVEILLANCE REGISTRY STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 637425 | SELECTSECURE | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | MPRI | 3830 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00075 YR | Required Intervention |