FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 1861714
·
Received October 8, 2010
Report
- Report Number
- 2649622-2010-09982
- Event Type
- Injury
- Date Received
- October 8, 2010
- Date of Event
- April 5, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S017
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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 OVERSENSING IS OCCURRING ON THE ATRIAL LEAD FOLLOWING ATRIAL PACES. IT WAS FURTHER REPORTED THAT OVERSENSING OCCURRED AT SEVERAL DIFFERENT PROGRAMMING CONFIGURATIONS. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS 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 | 77 YR | Required Intervention | 4076 IMPLANTABLE PACING LEAD| ADDR01 IMPLANTABLE PULSE GENERATOR |