MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPTA QUAD CRT-P MRI SURESCAN; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

Model Number W4TR01

Device Problems Failure to Capture (1081); High impedance (1291); Misconnection (1399)

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

Event Date 10/08/2019

Event Type  Injury  

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 competitor guidewire was being removed from the left ventricular (lv) lead and became stuck.The wire was pulled and broke within the lead.The lead was tested and the pacing threshold was observed to be the same and the impedance had increased.It was decided to utilize the lead and once the lead was connected to the cardiac resynchronization therapy defibrillator (crt-d), the only pacing configuration that was available was lv1 to can and the bipolar impedance measurements were high.It was noted following the procedure, there was no capture observed.The pocket was re-opened and it was noted the lv pin was not fully inserted in the header of the crt-d.The lead was tested and found to be within limits.The lead was reconnected; the device and lv lead remain in use.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.

Event Description

It was reported that during the implant procedure, the competitor guidewire was being removed from the left ventricular (lv) lead and became stuck.The wire was pulled and broke within the lead.The lead was tested and the pacing threshold was observed to be the same and the impedance had increased.It was decided to utilize the lead and once the lead was connected to the cardiac resynchronization therapy pacemaker (crt-p), the only pacing configuration that was available was lv1 to can and the bipolar impedance measurements were high.It was noted following the procedure, there was no capture observed.The pocket was re-opened and it was noted the lv pin was not fully inserted in the header of the crt-p.The lead was tested and found to be within limits.The lead was reconnected;the device and lv lead remain in use.No patient complications have been reported as a result of this event.

• Brand Name: PERCEPTA QUAD CRT-P MRI SURESCAN
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9283038
• MDR Text Key: 166978805
• Report Number: 3004209178-2019-21108
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00643169735644
• UDI-Public: 00643169735644
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/28/2019

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: 01/28/2021
• Device Model Number: W4TR01
• Device Catalogue Number: W4TR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 11/28/2019
• Supplement Dates FDA Received: 11/28/2019
• Date Device Manufactured: 07/30/2019
• 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: 87 YR