FDA Adverse Event
Injury
Summary report: N
CAPSURE Z
MDR report key: 1991407
·
Received February 15, 2011
Report
- Report Number
- 2649622-2011-02383
- Event Type
- Injury
- Date Received
- February 15, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P850089/S33
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, 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 T-WAVE OVERSENSING IS PRESENT ON THE LEAD. THE CALLER INDICATED THAT THERE MAY HAVE BEEN A LEAD MICRODISLODGEMENT IN THE PAST. THE CALLER MODIFIED THE DEVICE PROGRAMMING PARAMETERS IN ATTEMPT TO SENSE THE T-WAVES AS REFRACTORY EVENTS. 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 | CAPSURE Z | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 5034 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention | ADDR01 IMPLANTABLE PULSE GENERATOR| 4592 IMPLANTABLE PACING LEAD |