FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX
MDR report key: 1922741
·
Received December 13, 2010
Report
- Report Number
- 2649622-2010-13062
- Event Type
- Injury
- Date Received
- December 13, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WERE PAUSES ON THE ECG WITH FAST VENTRICULAR HIGH RATE EPISODES. AFTER OPENING THE PACEMAKER POCKET, AN INSULATION DEFECT WAS OBSERVED ON THE RIGHT VENTRICULAR LEAD. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSUREFIX | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4068 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | (B)(4) IMPLANTABLE PULSE GENERATOR |