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

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/06/2022

Event Type  Injury  

Event Description

The account reported an event wherein a patient received delayed care due to an ecg result that was not provided to the physician in a timely manner.In addition, the account alleged due to the delay in care the patient suffered an injury resulting from a syncopal episode.Following the event, the patient visited the er and a pacemaker was placed.Per the account, the patient is ¿okay¿.

Manufacturer Narrative

The device has been returned to the investigation facility and an investigation is underway.A follow up report will be submitted upon completion of the investigation.

Manufacturer Narrative

The delay in posting the report was caused by an initial registration discrepancy by the account, as well as communication and process gaps within the customer care team and the clinical operations team that receives the reprocessing requests.In the time between the patient wearing the device and irhythm posting the results, the patient suffered an injury resulting from a syncopal episode.The patient received delayed care due to the report not being provided to the physician in a timely manner.

• Brand Name: ZIO XT PATCH
• Type of Device: RECORDER, MAGNETIC TAPE, MEDICAL
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC; 699 8th st suite 600; san francisco CA 94103
• Manufacturer (Section G): IRHYTHM TECHNOLOGIES, INC; 11085 knott avenue suite b; cypress CA 90630
• Manufacturer Contact: mazi kiani ; 699 8th st suite 600; san francisco, CA 94103 ; 9494132147
• MDR Report Key: 15154468
• MDR Text Key: 297139021
• Report Number: 3007208829-2022-00039
• Device Sequence Number: 1
• Product Code: DSH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2022
• Initial Date FDA Received: 08/03/2022
• Supplement Dates Manufacturer Received: 07/06/2022
• Supplement Dates FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Female