FDA Adverse Event
Injury
Summary report: N
SECURA DR
MDR report key: 2952356
·
Received February 9, 2013
Report
- Report Number
- 3004209178-2013-01713
- Event Type
- Injury
- Date Received
- February 9, 2013
- Date of Event
- August 3, 2012
- Report Date
- November 4, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LWS
- PMA / PMN Number
- P980016/S114
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD: (B)(6) 2010. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS INTERROGATED, INVALID DATA APPEARED IN THE OBSERVATION TEXT, CARDIAC COMPASS AND HISTOGRAMS. THE PHYSICIAN WAS ABLE TO REPROGRAM THE SETTINGS AND THE ICD 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 |
|---|---|---|---|---|---|---|---|
| 56912 | SECURA DR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D224DRG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00077 YR | Required Intervention | 6947 IMPLANTABLE TACHY LEAD |