FDA Adverse Event
Injury
Summary report: N
SECURA DR
MDR report key: 1862931
·
Received October 9, 2010
Report
- Report Number
- 6000144-2010-05027
- Event Type
- Injury
- Date Received
- October 9, 2010
- Date of Event
- July 19, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S114
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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
IT WAS REPORTED THAT AFTER REPLACING AN IMPLANTED DEFIBRILLATOR (ICD) THE RIGHT VENTRICULAR LEAD IMPEDANCE, THE DEFIBRILLATION COIL IMPEDANCE AND THE STIMULATION THRESHOLDS WERE HIGH; ALSO, THERE WAS OVERSENSING. THE LEAD CONNECTION TO THE ICD WAS REVISED, SENSING RETURNED TO NORMAL AND THE SYSTEM REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SECURA DR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | D224DRG | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention | 4053 (BSX) IMPLANTABLE PACING LEAD |