INSYNC

MDR report key: 4313259 · Received December 10, 2014

Report

Report Number: 9614453-2014-02872
Event Type: Injury
Date Received: December 10, 2014
Date of Event: September 18, 2014
Report Date: September 18, 2014
Manufacturer: IPG MFG SWITZERLAND
Product Code: LWP
PMA / PMN Number: P010015
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

Additional Manufacturer Narrative · 1

A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCTS: 5076-52 LEAD IMPLANTED: 2002 (B)(6); 419378 LEAD IMPLANTED: 2002 (B)(6). (B)(4)

Description of Event or Problem · 1

IT WAS REPORTED THAT THE DEVICE EXHIBITED RV (RIGHT VENTRICULAR) ONLY PACING AT ERI (ELECTIVE REPLACEMENT INDICATOR). ADDITIONALLY, IT WAS REPORTED THAT THE DEVICE SHOULD HAVE REACHED ERI TWO TO THREE YEARS AGO AS IT WAS AT A HUNDRED PERCENT BIV (BIVENTRICULAR) PACING. IT WAS NOTED THAT THE PATIENT¿S EF (EJECTION FRACTION) HAD DROPPED FROM FORTY-FIVE PERCENT TO TWENTY PERCENT SINCE ERI. THE DEVICE WAS EXPLANTED AND UPGRADED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
800679	INSYNC	PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE	LWP	IPG MFG SWITZERLAND	8040

Patients

Seq	Age	Sex	Outcome	Treatment
1	00062 YR		Hospitalization\| R	5054-58 LEAD