FDA Adverse Event
Injury
Summary report: N
CAPSURE Z NOVUS
MDR report key: 2952272
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00487
- Event Type
- Injury
- Date Received
- February 9, 2013
- Date of Event
- November 14, 2012
- Report Date
- November 15, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089/S38
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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. A 6947 IMPLANTABLE TACHY LEAD: (B)(6) 2012; 4296 IMPLANTABLE PACING LEAD: 2012. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT POST-OP THE ATRIAL LEAD DISLODGED. THE LEAD HAD UNSTABLE THRESHOLDS AND WAS UNDERSENSING. THE LEAD WAS REPOSITIONED AND REMAINS 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 |
|---|---|---|---|---|---|---|---|
| 57065 | CAPSURE Z NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5554-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR | Hospitalization| R | D314TRM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |