INSYNC III

MDR report key: 3990687 · Received August 8, 2014

Report

Report Number: 3004209178-2014-14414
Event Type: Injury
Date Received: August 8, 2014
Date of Event: May 5, 2014
Report Date: May 5, 2014
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: LWP
PMA / PMN Number: P010015
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AL, 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

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 1346T, COMPETITOR LEAD, IMPLANTED: (B)(6) 2006; 1488T, COMPETITOR LEAD, IMPLANTED: (B)(6) 2000. (B)(4).

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING THE DEVICE HAD REACHED ERI (ELECTIVE REPLACEMENT INDICATOR) AND THERE WAS LOST CAPTURE UPON INTERROGATION. THE DEVICE WAS IN BACKUP PACING MODE AND THE PATIENT BECAME IMMEDIATELY SYMPTOMATIC WHEN THE PROGRAMMER HEAD WAS PLACED. IT WAS NOTED THE DEVICE MAY HAVE LOST INTERROGATION UPON ERI STATUS AND THAT THE DEVICE WAS UNABLE TO CAPTURE AT FULL OUTPUT. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
468184	INSYNC III	PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE	LWP	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	8042B

Patients

Seq	Age	Sex	Outcome	Treatment
1	00072 YR		Hospitalization\| R	507153, LEAD