FDA Adverse Event
Injury
Summary report: N
CAPSURE Z NOVUS
MDR report key: 2811711
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-16138
- Event Type
- Injury
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P850089/S38
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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 AT AN IN-OFFICE CHECK IT WAS NOTED THAT THERE WAS A HIGH OUTPUT WARNING DUE TO HIGH THRESHOLD ON THE RIGHT VENTRICULAR LEAD. OUTPUTS WERE INCREASED AND THE LOWER RATE WAS REDUCED. THE PATIENT IS IN ATRIAL FIBRILLATION. THE LEAD IS STILL 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 | CAPSURE Z NOVUS | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 5054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 93 YR | Required Intervention | 5554 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER |