FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 2130893
·
Received June 16, 2011
Report
- Report Number
- 2649622-2011-10292
- Event Type
- Injury
- Date Received
- June 16, 2011
- Date of Event
- April 8, 2011
- 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
- IA, 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 ONE DAY AFTER THE IMPLANT, THE LEAD WAS CHECKED AND SHOWED HIGH THRESHOLDS, LOW IMPEDANCE, AND LOWER SENSING. THE LEAD WAS REPOSITIONED. THE PHYSICIAN CONCLUDED THAT THE ISSUES WERE DUE TO A MICRO-DISLODGEMENT. 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 |
|---|---|---|---|---|---|---|---|
| 1 | CAPSUREFIX NOVUS | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 5076 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Hospitalization| R | 4470 COMPETITOR IMPLANTABLE PACING LEAD| S606 COMPETITOR IMPLANTABLE PULSE GENERATOR |