FDA Adverse Event
Injury
Summary report: N
CAPSURE SP
MDR report key: 1875047
·
Received October 19, 2010
Report
- Report Number
- 2649622-2010-11617
- Event Type
- Injury
- Date Received
- October 19, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P830061/S12
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
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
THERE WAS ATRIAL LEAD WARNING FOR LOW IMPEDANCE REPORTED. THE UNIPOLAR IMPEDANCE IS HIGHER THAN BIPOLAR. INNER INSULATION DEGRADATION WAS NOTED. IN ADDITION, THERE WAS POCKET STIMULATION AND THE PATIENT WAS FEELING SYMPTOMATIC. THE PATIENT WAS PROGRAMMED BIPOLAR WHEN POCKET STIMULATION OCCURRED. THE DEVICE IS IN USE. NO FURTHER 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 | 73 YR | Required Intervention | 4024 IMPLANTABLE PACING LEAD| MODEL SEDR01 IMPLANTABLE PACEMAKER/CARDIO/DEFIB |