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

Model Number DTMB1QQ

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Twiddlers Syndrome (2114)

Event Date 10/21/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 459878 lead; implanted: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the cardiac resynchronization therapy defibrillator (crt-d) migrated to the breast tissue.Additional information indicated that both the right ventricular (rv) lead and left ventricular (lv) lead had dislodged and that the lv lead exhibited low impedance.The physician was concerned about possible twiddlers.The crt-d, rv lead, and lv lead were explanted and replaced submuscular.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AMPLIA 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
• MDR Report Key: 9295812
• MDR Text Key: 165585984
• Report Number: 3004209178-2019-21331
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169543386
• UDI-Public: 00643169543386
• Combination Product (y/n): N
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/28/2018
• Device Model Number: DTMB1QQ
• Device Catalogue Number: DTMB1QQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 407652 LEAD, 6935M62 LEAD; 407652 LEAD, 6935M62 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 102