MAUDE Adverse Event Report: MEDTRONIC SOLARA QUAD CRTP; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

Model Number W4TR06

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 01/31/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that three days after the implant, the atrial and right ventricular leads had increased threshold and pacing failure.It was confirmed that both leads had dislodged.The atrial lead was repositioned without issue and remains in use.After repositioning the right ventricular lead several times, the impedance was high and undefined.When the lead polarity was changed it went back to an acceptable level.At that point, the physician suspected a possible anode coil fracture of the lead.The lead was explanted and a new lead was implanted with good impedance measurements.The physician also thought that possibly the device had moved which caused the lead dislodgements.The device remains in use.No patient complications have been reported as a result of this event.

• Brand Name: SOLARA QUAD CRTP
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
• Manufacturer (Section D): MEDTRONIC; 8200 coral sea st. n. e.; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC; 8200 coral sea st. n. e.; mounds view MN 55112
• Manufacturer Contact: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8374374
• MDR Text Key: 137277408
• Report Number: 2182208-2019-00379
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P010015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: W4TR06
• Device Catalogue Number: W4TR06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2019
• 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
• Treatment: 383069 LEAD, 383059 LEAD, 459888 LEAD