FDA Adverse Event
Injury
Summary report: N
SECURA DR
MDR report key: 2965017
·
Received February 15, 2013
Report
- Report Number
- 9614453-2013-00422
- Event Type
- Injury
- Date Received
- February 15, 2013
- Date of Event
- December 1, 2012
- Report Date
- December 2, 2012
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- LWS
- PMA / PMN Number
- P980016
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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 DEVICE: 5076 IMPLANTABLE PACING LEAD 2010 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY REMOTE TRANSMISSION, THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK DUE TO AN ATRIAL ARRHYTHMIA WITH RAPID VENTRICULAR RESPONSE. THE DEVICE WAS REMOVED AND AN UPGRADED DEVICE WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 68369 | SECURA DR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | IPG MFG SWITZERLAND | D224DRG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00070 YR | Life Threatening | 6947 IMPLANTABLE TACHY LEAD |