MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. QUADRA ALLURE MP CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM3562

Device Problems Intermittent Capture (1080); Over-Sensing (1438); Pacing Intermittently (1443)

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

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During follow-up, intermittent loss of capture was observed.Abbott technical support reviewed the session records and device printouts and found ectopic beats which were suspected to be interfering with pacing.In addition, high ventricular rate episodes were recorded.The patient experienced ventricular tachycardia so the device was upgraded to an icd.During the procedure, the left ventricular (lv) lead remained implanted and connected to the icd.However, the right ventricular lead was cut, capped and replaced during the procedure.The patient was stable with no adverse consequences.Related manufacturer reference number: 2017865-2020-07701, 2017865-2020-07702.

Manufacturer Narrative

The device was returned for analysis and visual inspection on device header did not find any anomalies that could contribute to the reported events.The device image analysis indicated average monthly voltage and current trends were normal.Output, sensitivity, and crosstalk tests were performed and no anomalies were noted.A longevity assessment was performed and device was in the normal range of operation with appropriate remaining longevity.The reported events of failure to capture, pacing problem, and oversensing were not confirmed.

• Brand Name: QUADRA ALLURE MP CRT-P
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10163021
• MDR Text Key: 195419208
• Report Number: 2017865-2020-07700
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734510097
• UDI-Public: 05414734510097
• Combination Product (y/n): N
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: PM3562
• Device Catalogue Number: PM3562
• Device Lot Number: P000088467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1458QL/86, (B)(4); 2088TC/58, (B)(4) ; 1458QL/86, (B)(4); 2088TC/58, (B)(4)
• Patient Age: 18 YR