FDA Adverse Event Injury Summary report: N

TRI-AD BAND

MDR report key: 9416350 · Received December 5, 2019

Report

Report Number: 2025587-2019-03678
Event Type: Injury
Date Received: December 5, 2019
Date of Event: October 28, 2019
Report Date: December 5, 2019
Manufacturer: MEDTRONIC HEART VALVES DIVISION
Product Code: KRH
UDI-DI: 00763000102302
PMA / PMN Number: K093903
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 310C27, SERIAL/LOT #: (B)(4), UBD: 13-NOV-2023, UDI#: (B)(4), PMA/510(K): P990064, IMPLANT DATE: (B)(6) 2019. PRODUCT ANALYSIS: THE DEVICES REMAIN IMPLANTED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCTS, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. CONDUCTION DISTURBANCES ARE KNOWN POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH ANY CARDIAC OR THORACIC PROCEDURE AND CAN BE RESOLVED WITH MEDICAL TREATMENT OR THE IMPLANT OF A PERMANENT PACEMAKER (WITH THE RISK-BENEFIT RATIO IN FAVOR OF IMPLANT STRUCTURAL HEART PRODUCTS). A CONDUCTION DISTURBANCE DOES NOT INDICATE A DEVICE MALFUNCTION OR POTENTIAL MANUFACTURING ISSUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

MEDTRONIC RECEIVED INFORMATION THAT 4 DAYS POST IMPLANT OF THIS MITRAL BIOPROSTHETIC VALVE AND TRICUSPID ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO ATRIO-VENTRICULAR (AV) BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1210806	TRI-AD BAND	RING, ANNULOPLASTY	KRH	MEDTRONIC HEART VALVES DIVISION	900SFC226		00763000102302

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR		Required Intervention