FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX
MDR report key: 1925630
·
Received December 14, 2010
Report
- Report Number
- 2649622-2010-13961
- Event Type
- Injury
- Date Received
- December 14, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S2
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, 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 ATRIAL LEAD HAD HIGH THRESHOLDS. DURING THE REPLACEMENT PROCEDURE, THE PHYSICIAN WAS UNABLE TO INSERT THE GUIDEWIRE DUE TO VEINOUS OCCLUSION. THE PHYSICIAN DECIDED TO CONTINUE USING THE LEAD. 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 | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4568 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Hospitalization| R | 7275 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6930 IMPLANTABLE TACHY LEAD |