FDA Adverse Event Injury Summary report: N

REVEAL LINQ

MDR report key: 3990664 · Received August 8, 2014

Report

Report Number: 9614453-2014-01767
Event Type: Injury
Date Received: August 8, 2014
Date of Event: May 28, 2014
Report Date: May 28, 2014
Manufacturer: IPG MFG SWITZERLAND
Product Code: DSI
PMA / PMN Number: K132649
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NL
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED RV (RIGHT VENTRICULAR) UNDERSENSING INFORMATION. EPISODE DATA SHOWS ASYSTOLE EPISODE IN PROGRESS ON (B)(6) 2014.

Description of Event or Problem · 1

IT WAS REPORTED THAT DIRECTLY AFTER IMPLANT, THE IMPLANTABLE CARDIAC MONITOR (ICM) SHOWED NO INFORMATION OR R WAVES ON THE ELECTROGRAM, ALTHOUGH PAUSES CONTINUED. THE PATIENT WAS SENT HOME AND APPROXIMATELY TWO WEEKS LATER, THE PATIENT WAS SEEN AND THERE WAS STILL NO ACTIVITY ON THE ICM. THE ICM WAS REMOVED FROM THE POCKET AND FOUND TO HAVE CRYSTALLIZATION ON THE SKIN AND PERHAPS THE ELECTRODES WHICH WAS THOUGHT TO BE MEDICAL ADHESIVE. THE ICM WAS STERILIZED AND REINSERTED INTO THE POCKET WITH INCREASED SIGNAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
472732	REVEAL LINQ	DETECTOR AND ALARM, ARRHYTHMIA	DSI	IPG MFG SWITZERLAND	LNQ11

Patients

Seq	Age	Sex	Outcome	Treatment
1	00090 YR		Hospitalization\| R