MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ASSURITY RF DR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM2240

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); No Device Output (1435); Pacemaker Found in Back-Up Mode (1440); No Pacing (3268); Wireless Communication Problem (3283)

Patient Problem Discomfort (2330)

Event Date 04/17/2020

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that patient presented to clinic on (b)(6) 2020 with discomfort in their armpit and shoulder region.Upon initial interrogation of the pacemaker, the programmer had trouble locating the device.Once the programmer located the device, it was only intermittent.The pacemaker was found to be in backup vvi mode caused by the device trying to store data in an area that had not been mapped.The programmer was unable to stay connected to the pacemaker long enough to do anything further than to create a print out.An electrocardiogram and x-ray was performed.The physician then decided to explant and replace the pacemaker on (b)(6) 2020.Patient condition post-procedure was stable.

Manufacturer Narrative

Additional analysis: the reported events of backup operation and inability to interrogate were confirmed.As received, the device battery was at end of service (eos) voltage level and output anomalies were observed.The device was cut open to enable further testing and the battery was found depleted.Hybrid circuitry was tested by connecting to an external power source and results indicated high current drain.Additional tests were performed by separating the header from the case to perform a dye penetration test on the feedthrough component.Test results indicated a feedthrough breach affecting the devices hermeticity, resulting in damage to the hybrid and battery depletion, consistent with the reported events.Additionally, visual inspection of the header attachment area also revealed header delamination occurring between the header and case.As a result of these findings of a feedthrough breach and header delamination, abbott is performing further investigation.

Event Description

New information received notes that the pacemaker displayed no output, failure to capture, and noise on the atrial and right ventricular channels during the generator change.

Manufacturer Narrative

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

Manufacturer Narrative

The reported events of backup operation and inability to interrogate were confirmed.Final analysis found hybrid circuitry was consistent with a latch-up condition, which cleared after hybrid power was reset.Additional tests indicated a feedthrough breach affecting the devices hermeticity, resulting in damage to the hybrid and battery depletion, consistent with the reported events.As a result of this finding, abbott is performing further investigation.Visual inspection of the header attachment area also revealed header delamination occurring between the header and case.As a result of this finding, abbott is performing further investigation.

Manufacturer Narrative

The device is included in the assurity and endurity pacemakers header anomaly advisory issued by abbott on 15 march 2021.

• Brand Name: ASSURITY RF DR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10022852
• MDR Text Key: 189834538
• Report Number: 2017865-2020-05725
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507073
• UDI-Public: 05414734507073
• Combination Product (y/n): N
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/31/2021

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: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: PM2240
• Device Catalogue Number: PM2240
• Device Lot Number: A000030284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2020
• Initial Date FDA Received: 05/04/2020
• Supplement Dates Manufacturer Received: 06/10/2020; 09/22/2020; 09/28/2020; 03/24/2021; 03/15/2021
• Supplement Dates FDA Received: 06/18/2020; 09/23/2020; 09/28/2020; 03/24/2021; 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q121-CRM-1
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Weight: 66