FDA Adverse Event
Malfunction
Summary report: N
CAPSURE SENSE
MDR report key: 1921500
·
Received December 13, 2010
Report
- Report Number
- 2649622-2010-12563
- Event Type
- Malfunction
- Date Received
- December 13, 2010
- Date of Event
- August 21, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P830061/S034
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 IMPEDANCE AND THAT AN ATRIAL LEAD WARNING RECENTLY OCCURRED. THE PATIENT WAS ALSO REPORTED TO BE 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 SENSE | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4574 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other | 4074 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR |