FDA Adverse Event Injury Summary report: N

PROTECTA XT CRT-D

MDR report key: 4830238 · Received June 10, 2015

Report

Report Number: 3004209178-2015-10943
Event Type: Injury
Date Received: June 10, 2015
Date of Event: April 16, 2015
Report Date: April 16, 2015
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: NIK
PMA / PMN Number: P010031
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, 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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND 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. (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 THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO SUSPECTED EARLY BATTERY DEPLETION. THE ICD WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT THE PATIENT'S LEFT VENTRICULAR (LV) LEAD HAD FAIRLY HIGH THRESHOLDS. THE LV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
376677	PROTECTA XT CRT-D	DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO	NIK	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	D314TRG

Patients

Seq	Age	Sex	Outcome	Treatment
1	00061 YR		Hospitalization\| R	429678 LEAD, 5076-45 LEAD, 694765 LEAD