FDA Adverse Event Malfunction Summary report: N

CARDIOMEMS PATIENT ELECTRONIC SYSTEM

MDR report key: 18103402 · Received November 9, 2023

Report

Report Number: 3004936110-2023-01652
Event Type: Malfunction
Date Received: November 9, 2023
Date of Event: October 9, 2023
Report Date: November 9, 2023
Manufacturer: ST. JUDE MEDICAL, INC.
Product Code: MOM
UDI-DI: 05414734509800
PMA / PMN Number: P100045
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

ONE CARDIOMEMS PATIENT ELECTRONIC SYSTEM WAS RECEIVED FOR EVALUATION. INTERNAL VISUAL INSPECTION INSIDE UNIT¿S ENCLOSURE ASSEMBLY REVEALED MULTIPLE BURNT COMPONENTS ON THE ANTENNA TX/ RX PORTIONS OF I3 STUFFED PCA (600235017). UNIT BOOTED UP CORRECTLY TO THE START SCREEN ON THE HANDHELD WITHOUT EVER PRODUCING ANY SOFTWARE ERRORS OR WARNINGS. A REVIEW OF THE DHR WAS PERFORMED FOR BATCH #8850035 AND RULED OUT THE POSSIBILITY OF A MANUFACTURING RELATED ISSUE CAUSING OR CONTRIBUTING TO THE REPORTED COMPLAINT ISSUE, AS NO NON-CONFORMANCE RELATED TO THE REPORTED ISSUE WAS FOUND IN THE BATCH RECORDS REVIEWED.

Description of Event or Problem · 0

THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING THERMAL DAMAGE ON MULTIPLE BURNT COMPONENTS ON THE ANTENNA TX/ RX PORTIONS OF I3 STUFFED PCA (600235017).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
91790	CARDIOMEMS PATIENT ELECTRONIC SYSTEM	System, hemodynamic, implantable	MOM	ST. JUDE MEDICAL, INC.	CM1100	8850035	05414734509800

Patients

Seq	Age	Sex	Outcome	Treatment
1	89 YR	Female