FDA Adverse Event
Injury
Summary report: N
SECURA DR
MDR report key: 1854755
·
Received October 5, 2010
Report
- Report Number
- 6000144-2010-04408
- Event Type
- Injury
- Date Received
- October 5, 2010
- Date of Event
- April 23, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S114
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PATIENT
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
THE PATIENT'S WIFE REPORTED THAT THE PATIENT HAS RECEIVED FOUR SHOCKS SINCE DEVICE IMPLANT IN APRIL. IT WAS FURTHER REPORTED THAT "THEY TOLD US HE MAY NEED AN ABLATION". THE PATIENT'S WIFE ALSO REPORTED THAT ADJUSTMENTS WERE MADE AFTER THE FIRST SHOCK. THE DEVICE 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 | SECURA DR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | D224DRG | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention | 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD |