FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 4160757
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-11755
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- July 3, 2014
- Report Date
- July 3, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, 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. MODEL: 407652, LEAD; IMPLANT: (B)(6) 2014. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENTS RIGHT VENTRICULAR (RV) LEAD EXPERIENCED A MICRODISLODGEMENT. AN INTERVENTION WAS COMPLETED TO REPOSITION THE LEAD. THE LEAD 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 |
|---|---|---|---|---|---|---|---|
| 641707 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 407658 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00080 YR | Hospitalization| R | SEDR01, IPG |