FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 1922055
·
Received December 13, 2010
Report
- Report Number
- 2649622-2010-12737
- Event Type
- Injury
- Date Received
- December 13, 2010
- Date of Event
- September 6, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S017
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN EXPLANT PROCEDURE, THE ATRIAL LEAD DISLODGED. THE ATRIAL LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSUREFIX NOVUS | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4076 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Hospitalization| R | (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6931 IMPLANTABLE TACHY LEAD |