FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 2813564
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-16774
- Event Type
- Injury
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, 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 THE RIGHT VENTRICULAR LEAD WAS FRACTURED. THE LEAD HAD HIGH THRESHOLDS AND NOISE ON ELECTROGRAM (EGM) WHICH TRIGGERED A LEAD ALERT. WHEN THE LEAD WAS CHECKED THROUGH THE ANALYZER IT SHOWED NOISE AND NO SENSING. WHEN THE PHYSICIAN APPLIED PRESSURE TO THE LEAD DEEP IN THE POCKET THERE WERE INTERMITTENT PERIODS OF CLEAR VEGM. THE PHYSICIAN WAS UNABLE TO VISUALIZE THE LEAD IN THAT AREA. THE LEAD WAS CAPPED AND 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. | 5076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization| R | 4068 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR |