FDA Adverse Event
Malfunction
Summary report: N
SECURA DR
MDR report key: 3992469
·
Received August 8, 2014
Report
- Report Number
- 3004209178-2014-14824
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- June 2, 2014
- Report Date
- June 3, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LWS
- PMA / PMN Number
- P980016
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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 MEDICAL PRODUCTS: MODEL: 5076-52, LEAD, IMPLANT: (B)(6) 2006. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENTS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MISINTERPRETED A SUPRAVENTRICULAR TACHYCARDIA (SVT) AS A VENTRICULAR TACHYCARDIA (VT) RESULTING IN A INAPPROPRIATE ANTITACHYCARDIA PACING (ATP) THERAPY. 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 |
|---|---|---|---|---|---|---|---|
| 466791 | SECURA DR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D224DRG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00064 YR | 693565, LEAD |