FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 2203256
·
Received August 11, 2011
Report
- Report Number
- 2649622-2011-11672
- Event Type
- Injury
- Date Received
- August 11, 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
- ND, 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 PATIENT WAS PRESENTED TO THE EMERGENCY ROOM WITH COMPLETE HEART BLOCK AND NO CAPTURE OF THE RIGHT VENTRICULAR LEAD. THE LEAD FRACTURED AND HAD POSITIONAL INTERMITTENT CAPTURE. THE LEAD HAD UNACCEPTABLE THRESHOLDS, HIGH IMPEDANCE, AND OVER SENSING. 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 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Hospitalization| L| R | (B)(4) IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD |