FDA Adverse Event
Malfunction
Summary report: N
CAPSURE SP
MDR report key: 1791094
·
Received August 10, 2010
Report
- Report Number
- 2649622-2010-07016
- Event Type
- Malfunction
- Date Received
- August 10, 2010
- Date of Event
- March 30, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P830061/S12
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- WA, 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. EVALUATION SUMMARY: (B)(4) ANALYSIS REVEALED NORMAL BATTERY DEPLETION.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN LOOKING AT THE EGM IT LOOKED LIKE THERE WAS ATRIAL FIBRILLATION OR NOISE; THE PATIENT WAS PRONE TO ATRIAL FIBRILLATION. IT WAS ALSO REPORTED THERE WAS CONCERN ABOUT THE DUAL EGM. THE DEVICE WAS EXPLANTED AND REPLACED. 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 SP | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4524 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention | 4024 IMPLANTABLE PACING LEAD |