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

Model Number PM2272

Device Problems Premature Discharge of Battery (1057); Premature End-of-Life Indicator (1480); Premature Elective Replacement Indicator (1483)

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

Event Date 11/15/2020

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 patient presented for in-clinic follow up for routine interrogation of the pulse generator.It was observed the elective replacement indicator was triggered on (b)(6) 2020 and the device reach end of service on 04 (b)(6) 2020.Premature battery depletion was suspected.The patient was in stable condition while awaiting scheduled device replacement.

Event Description

New information received notes that the pulse generator was explanted and replaced.The patient was in stable condition.

Manufacturer Narrative

The reported event of premature battery depletion was confirmed.As received, the device had no output.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, resulting in unusually low current drain, consistent with hybrid anomaly condition from moisture damage, 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 (b)(6) 2021.

• Brand Name: ASSURITY MRI
• 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: 11109525
• MDR Text Key: 224827684
• Report Number: 2017865-2021-00074
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509589
• UDI-Public: 05414734509589
• Combination Product (y/n): N
• PMA/PMN Number: P140033
• 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
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: PM2272
• Device Catalogue Number: PM2272
• Device Lot Number: A000039249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2021
• 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