FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 1925437
·
Received December 14, 2010
Report
- Report Number
- 2649622-2010-13859
- Event Type
- Injury
- Date Received
- December 14, 2010
- Date of Event
- September 29, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S009
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS HIGH IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS EXTRACTED AND REPLACED. DURING RV LEAD REVISION THE RIGHT ATRIUM (RA) LEAD WAS DISLODGED. THE DOCTOR WAS CONCERNED THERE MAY BE TISSUE ON THE RA LEAD IMPEDING FIXATION AND CHOSE TO EXPLANT AND REPLACE. NO FURTHER PATIENT COMPLICATIONS WERE 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. | 5076 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization| R | 7274 IMPLANTABLE PACEMAKER/CARDIO/DEFIB |