FDA Adverse Event
Injury
Summary report: N
ENTRUST VR
MDR report key: 2883887
·
Received December 21, 2012
Report
- Report Number
- 3004209178-2012-12169
- Event Type
- Injury
- Date Received
- December 21, 2012
- Report Date
- December 19, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LWS
- PMA / PMN Number
- P980016/S046
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, 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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC AFTER NOT HAVING BEEN SEEN SINCE 2008. INTERROGATION OF THE DEVICE NOTED TWO EPISODES WHERE INAPPROPRIATE THERAPY WAS DELIVERED FOR WHAT APPEARED TO BE SUPRAVENTRICULAR TACHYCARDIA. ONE EPISODE OCCURRED IN 2009 AND THE SECOND IN 2012. DEVICE PROGRAMMING WAVELET DETECTION CHANGES WERE MADE AND THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTRUST VR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D153VRC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| R | (B)(4) COMPETITOR IMPLANTABLE TACHY LEAD |