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

Model Number W4TR01

Device Problem Under-Sensing (1661)

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

Event Date 04/07/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that there was undersensing of some non-hemodynamic fine morphology waves during an episode that was classified as ventricular tachycardia (vt) by the device.The device was subsequently explanted and replaced.No patient complications have been reported as a result of this event.

• Brand Name: PERCEPTA QUAD 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: 7483095
• MDR Text Key: 107223314
• Report Number: 3004209178-2018-09968
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00643169735644
• UDI-Public: 00643169735644
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/28/2018
• Device Model Number: W4TR01
• Device Catalogue Number: W4TR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2017
• 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
• Treatment: 5076-52 LEAD, 439888 LEAD, 5076-45 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR