FDA Adverse Event
Injury
Summary report: N
SECURA DR
MDR report key: 2053409
·
Received April 13, 2011
Report
- Report Number
- 6000144-2011-01617
- Event Type
- Injury
- Date Received
- April 13, 2011
- Date of Event
- February 3, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S114
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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. EVALUATION SUMMARY: (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. VENTRICULAR SHORT INTERVAL COUNT V-SIC=3511.1 COUNTS AVG/DAY, IN 0.90 DAY, BETWEEN (B)(6) 2011 13:44:55 AND (B)(6) 2011 11:20:05.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD RECORDED A LARGE NUMBER OF SHORT INTERVALS SINCE IMPLANT. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS WERE 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 | 65 YR | Required Intervention | 4076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD |