FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 2811513
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-16125
- Event Type
- Injury
- Date Received
- October 31, 2012
- Date of Event
- September 18, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S017
- 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 HAD DIMINISHED R-WAVES AFTER THE LEAD WAS CONNECTED TO THE DEVICE AND THE POCKET WAS CLOSED. FLUOROSCOPY REVEALED THAT THE LEAD SEEMED TO BE IN A SIMILAR POSITION AS BEFORE THE LEAD WAS CONNECTED TO THE DEVICE AND THE POCKET WAS CLOSED, HOWEVER THE POCKET WAS OPENED AND THE LEAD WAS REPOSITIONED. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE 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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization| R | SESR01 IMPLANTABLE PULSE GENERATOR |