MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC ZIO XT PATCH; RECORDER, MAGNETIC TAPE, MEDICAL

Lot Number N936017569

Device Problems Loss of or Failure to Bond (1068); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2019

Event Type  malfunction  

Event Description

I rhythm zio xt patch failed after two days of adhesion.The adhesive used to attach the heart rhythm monitor is faulty, the unit is (b)(4); pt: (b)(6).Fda safety report id# (b)(4).

• Brand Name: ZIO XT PATCH
• Type of Device: RECORDER, MAGNETIC TAPE, MEDICAL
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC
• MDR Report Key: 8776253
• MDR Text Key: 150741489
• Report Number: MW5087973
• Device Sequence Number: 0
• Product Code: DSH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: N936017569
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 73