MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO PROTECTA XT CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number D314TRM

Device Problem Component Missing (2306)

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

Event Date 06/12/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 407652 lead, implanted: (b)(6) 2005; 6935m62 lead, implanted: (b)(6) 2013.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a replacement procedure, the physician was unable to unscrew the atrial setscrew in the cardiac resynchronization therapy defibrillator (crt-d).It felt that there was nothing for the wrench to grip and it was discovered that the atrial lead set screw was missing in the device.The atrial lead was pulled directly out of the header without unscrewing.The device was explanted and replaced.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Analysis of the device revealed normal battery depletion.The battery indicator signifying that it is time for device replacement occurred after explant.The returned device indicated a missing grommet and a missing set screw.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTECTA XT CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6781654
• MDR Text Key: 82338301
• Report Number: 3004209178-2017-16864
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00613994714589
• UDI-Public: 00613994714589
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/12/2017

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/14/2014
• Device Model Number: D314TRM
• Device Catalogue Number: D314TRM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2017
• Initial Date FDA Received: 08/09/2017
• Supplement Dates Manufacturer Received: 08/21/2017
• Supplement Dates FDA Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 61 YR