MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPTA CRTP; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

Model Number W1TR01

Device Problems Break (1069); Mechanical Problem (1384)

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

Event Date 06/12/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during the implant procedure, the cardiac resynchronization therapy pacemaker (crt-p) had a broken set screw.It was noted that the lead could not be screwed into the device.The device was not used, and another device was implanted.No patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

Product event summary : the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.This device was reported as included in the field action noted but returned product investigation found the device did not perform as described in the field action.The device is no longer included as part of the field action.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PERCEPTA CRTP
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7671418
• MDR Text Key: 113639620
• Report Number: 3004209178-2018-15329
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00643169735637
• UDI-Public: 00643169735637
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/14/2019
• Device Model Number: W1TR01
• Device Catalogue Number: W1TR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2412-2018
• Patient Sequence Number: 1
• Patient Age: 63 YR