FDA Adverse Event Injury Summary report: N

KAPPA DDDR 900

MDR report key: 10656094 · Received October 9, 2020

Report

Report Number: 3004209178-2020-17627
Event Type: Injury
Date Received: October 9, 2020
Date of Event: September 18, 2020
Report Date: October 9, 2020
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: DXY
PMA / PMN Number: P980035
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: DTMB1D4 CRT-D, IMPLANTED: (B)(6) 2020, 6935M55, LEAD, IMPLANTED: (B)(6) 2016, 419588, LEAD, IMPLANTED: (B)(6) 2010, 5076-45, LEAD, IMPLANTED: (B)(6) 2010, 033-464, LEAD, IMPLANTED: (B)(6) 1995. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) ON THE PATIENT¿S RIGHT SIDE AND THE PREVIOUSLY INACTIVATED IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM ON THE PATIENT¿S LEFT SIDE WERE EXPLANTED DUE TO A POCKET INFECTION. DURING THE EXPLANT PROCEDURE, ONLY THE RIGHT ATRIAL (RA) LEAD WAS ABLE TO BE EXTRACTED DUE TO ALL THE OTHER LEADS BEING ADHERED TO THE CLAVICLE. A TEMPORARY LEAD AND SYSTEM WERE IMPLANTED AS BACK UP AS THE PATIENT WAS PACEMAKER DEPENDENT. ONE WEEK LATER, THE REST OF THE LEADS AND BOTH SYSTEMS WERE REMOVED. IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD, WHICH WAS INACTIVATED DURING THE PROCEDURE ONE WEEK PRIOR, WAS PARTIALLY REMOVED. AN EPICARDIAL SYSTEM WAS IMPLANTED IN THE PATIENT¿S ABDOMEN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1122035	KAPPA DDDR 900	PULSE-GENERATOR, PACEMAKER, IMPLANTABLE	DXY	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	KDR921

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR		Hospitalization\| R