MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. CLARIA MRI QUAD CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTMA1QQ

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Fall (1848); Discomfort (2330); Twiddlers Syndrome (4563)

Event Date 05/21/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by the patient that they experienced a fall.It was determined post-examination that "some of the leads had come loose." additional information reported the cardiac resynchronization therapy defibrillator (crt-d) protruded out of the pocket site and moved to the patient's armpit area, which caused emotional and physical discomfort, and anxiety for the patient.Follow up revealed an x-ray was performed and the leads appeared to be twisted and pulled back, possibly due to twiddler syndrome.The right atrial (ra) lead was programmed off due to non-capture.The left ventricular (lv) lead was programmed off due to no synchrony related to the ra lead.The cardiac resynchronization therapy defibrillator (crt-d) and the rv lead remain in use.No further patient complications have been reported as a result of this event.

• Brand Name: CLARIA MRI QUAD CRT-D SURESCAN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 12600367
• MDR Text Key: 278390218
• Report Number: 3004209178-2021-15099
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169720633
• UDI-Public: 00643169720633
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/28/2021
• Device Model Number: DTMA1QQ
• Device Catalogue Number: DTMA1QQ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2021
• Date Device Manufactured: 03/11/2020
• 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 Age: 60 YR
• Patient Weight: 36