FDA Adverse Event
Injury
Summary report: N
CAPSURE SP
MDR report key: 2790635
·
Received October 15, 2012
Report
- Report Number
- 2649622-2012-14156
- Event Type
- Injury
- Date Received
- October 15, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P830061/S12
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, 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 THE PATIENT FELT INTERMITTENT PACING AT THE SAME TIME EVERY NIGHT. THE CHRONIC LEAD TREND WAS TURNED OFF AND SINCE THEN THERE HAVE BEEN NO REPORTS OF INTERMITTENT PACING FROM THE PATIENT. 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. | 4024 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Required Intervention | (B)(4) IMPLANTABLE PULSE GENERATOR| 4524 IMPLANTABLE PACING LEAD |