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

Model Number PM2240

Device Problem Failure to Interrogate (1332)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient presented to the emergency room.Interrogation of the pacemaker was attempted but was unsuccessful using inductive telemetry.The device did not have any pacing response when a magnet was placed over the device.A telemetry test was attempted but was also unsuccessful.It was believed that the device may be dead, and there is no allegation of premature battery depletion from the physician.The device was explanted and replaced, and the patient was in stable condition throughout with no consequences.

Manufacturer Narrative

The reported event of inability to interrogate was confirmed.As received, the device had no telemetry communication and was in backup mode.Visual inspection of the header attachment area detected a bonding anomaly.A device hermeticity breach was observed, consistent with feedthrough 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 the battery was found depleted to end-of-service level.Hybrid circuitry was tested indicating elevated current drain, consistent with moisture damage, depleting the battery and resulting in the reported event.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: 11099273
• MDR Text Key: 224517891
• Report Number: 2017865-2020-25322
• 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: 04/01/2021

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: 07/31/2018
• Device Model Number: PM2240
• Device Catalogue Number: PM2240
• Device Lot Number: A000034675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 01/22/2021; 03/15/2021
• Supplement Dates FDA Received: 01/27/2021; 04/02/2021
• 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: 84 YR
• Patient Weight: 64