FDA Adverse Event Injury Summary report: N

ADAPTA

MDR report key: 2964376 · Received February 15, 2013

Report

Report Number: 3004209178-2013-02059
Event Type: Injury
Date Received: February 15, 2013
Date of Event: December 4, 2012
Report Date: December 4, 2012
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: NVZ
PMA / PMN Number: P980035
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

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. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD: (B)(6) 2012. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO FEELING LIGHT HEADED AND DIZZY. IT WAS DISCOVERED THE DEVICE SET SCREWS WERE LOOSE FOR THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD. DURING THE LEAD REVISION, BOTH OF THE LEADS WERE EASILY REMOVED FROM THE DEVICE CONNECTOR PORTS. BOTH OF THE LEADS WERE TESTED AND FOUND TO BE WORKING SATISFACTORILY AND WERE REINSERTED INTO THE DEVICE AND THE SET SCREWS WERE PROPERLY TIGHTENED. THE DEVICE AND BOTH LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
68211	ADAPTA	PULSE GENERATOR, PERMANENT, IMPLANTABLE	NVZ	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	ADDR01

Patients

Seq	Age	Sex	Outcome	Treatment
1	00078 YR		Hospitalization\| R	5554 IMPLANTABLE PACING LEAD