FDA Adverse Event Injury Summary report: N

REVEAL DX

MDR report key: 1863214 · Received October 9, 2010

Report

Report Number: 6000144-2010-05109
Event Type: Injury
Date Received: October 9, 2010
Date of Event: July 4, 2010
Manufacturer: MEDTRONIC MED REL, INC.
Product Code: DSI
PMA / PMN Number: K071655
Removal / Correction Number: ASKU
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: 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.

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 DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

Description of Event or Problem · 1

IT WAS REPORTED THAT A FAST VENTRICULAR TACHYARRHYTHMIA (FVT) EPISODE COLLECTED ON CARELINK APPEARED NON-PHYSIOLOGIC. THE PATIENT WAS SLEEPING AT THE TIME AND DOES NOT RECALL ANY SYMPTOMS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT A FAST VENTRICULAR TACHYARRHYTHMIA (FVT) EPISODE COLLECTED ON CARELINK APPEARS NON-PHYSIOLOGIC. THE PATIENT WAS SLEEPING AT THE TIME AND DOES NOT RECALL ANY SYMPTOMS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED TO ALLEVIATE PATIENT PAIN. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	REVEAL DX	IMPLANTABLE LOOP RECORDER	DSI	MEDTRONIC MED REL, INC.	9528	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	42 YR		Hospitalization\| O\| R