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

Model Number PM2272

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Unspecified Infection (1930)

Event Date 09/08/2021

Event Type  Injury  

Event Description

Related manufacturer reference numbers: 2017865-2021-31337.Related manufacturer reference numbers: 2017865-2021-31338.It was reported that the patient presented remotely via merlin.Net.Upon review, it was found that the right ventricular (rv) lead exhibited r-wave amplification variation.Upon in-clinic interrogation, both rv and atrial lead exhibited over-sensing with no capture, and the atrial lead exhibited mode switch and high capture threshold as well.The over-sensing on the atrial lead was noted to be far r-wave over-sensing.It was stated that the pacemaker (pm) had flipped under the skin multiple times.During lead revision procedure, it was found that the pocket was infected.The whole system was explanted.Patient condition was stable.

• 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: 12533547
• MDR Text Key: 273362899
• Report Number: 2017865-2021-31336
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: PM2272
• Device Catalogue Number: PM2272
• Device Lot Number: A000106942
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 09/27/2021
• Supplement Dates Manufacturer Received: 11/02/2021; 11/04/2021
• Supplement Dates FDA Received: 11/02/2021; 11/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TENDRIL STS.; TENDRIL STS.; TENDRIL STS; TENDRIL STS
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 101