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

Model Number PM2240

Device Problems Failure to Interrogate (1332); No Pacing (3268)

Patient Problems Syncope (1610); Syncope/Fainting (4411)

Event Date 11/30/2020

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 the pacemaker dependent patient presented to the emergency room due to syncopal episodes.An interrogation was attempted however, was not successful.It was noted that the pacing was possibly interrupted but it is unknown if the device contributed or not.The device was explanted and replaced.The patient was in stable condition.

Manufacturer Narrative

The reported events of inability to interrogate and no pacing output were confirmed.As received, the device had no telemetry communication and no output.Visual inspection of the header attachment area detected a bonding anomaly.A device hermeticity breach was observed, consistent with feed through damage as a result of fluid intrusion between the header and case, and subsequent fluid ingress to the internal electronics.The device was cut open to enable further testing and battery was found depleted.Hybrid circuitry was tested, resulting in high current drain, consistent with moisture damage, depleting the battery and resulting in the reported events.A manufacturing anomaly may have occurred, which resulted in the header bonding anomaly.As a result of this finding, abbott is performing further investigation.

Manufacturer Narrative

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: 11032770
• MDR Text Key: 222277582
• Report Number: 2017865-2020-23083
• 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
• 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: 11/30/2017
• Device Model Number: PM2240
• Device Catalogue Number: PM2240
• Device Lot Number: A000023222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 01/29/2021; 03/15/2021
• Supplement Dates FDA Received: 02/08/2021; 04/01/2021
• 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: 78 YR
• Patient Weight: 109