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
Medical Device Problem Codes	Failure to Capture (1081); High impedance (1291); Misconnection (1399)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: 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
• MDR Report Key: 9283038
• Report Number: 3004209178-2019-21108
• Device Sequence Number: 135607
• Product Code: NKE
• UDI-Device Identifier: 00643169735644
• UDI-Public: 00643169735644
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/28/2021
• Device Model Number: W4TR01
• Device Catalogue Number: W4TR01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 11/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 87 YR