FDA Adverse Event
Injury
Summary report: N
CAPSURE Z NOVUS
MDR report key: 2964867
·
Received February 15, 2013
Report
- Report Number
- 2649622-2013-02032
- Event Type
- Injury
- Date Received
- February 15, 2013
- Date of Event
- December 8, 2012
- Report Date
- December 8, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, 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. (B)(6).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM COMPLAINING OF A "SICKING FEELING" IN THE LOWER ABDOMEN. HIGH THRESHOLDS ON BOTH LEADS WERE NOTED, ALONG WITH INTERMITTENT LOSS OF CAPTURE. THE RV (RIGHT VENTRICULAR) LEAD OUTPUT WAS REPROGRAMMED, AND BOTH LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 69258 | CAPSURE Z NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5054-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00070 YR | Hospitalization| R | SEDR01 IMPLANTABLE PULSE GENERATOR |