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

Model Number PM1140

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2021

Event Type  malfunction  

Event Description

During an initial implant procedure on (b)(6) 2021, it was noted that the header of the pacemaker (pm) could not connect with the lead due to insertion difficulties regrading the connector port.The pm was not used and a new pm was successfully implanted.The patient was stable throughout the procedure.

Event Description

Additional information received indicated that the set screw of the pacemaker (pm) was also loose, creating an intermittent connection with the lead.

Manufacturer Narrative

The reported event of unable to tighten the setscrew onto the lead was confirmed.Analysis revealed cross-threading of the setscrew into the connector block threads prevent the setscrew from tightening down on the lead to secure it in the header.The incorrect installation of the setscrew post manufacturing rework and epoxy fragments found on the sides of the setscrew head may have contributed to the setscrew cross-threading, which resulted in the reported event.The cause of the reported event was due to a manufacturing anomaly.

• Brand Name: SBP SR INDUCTIVE PACEMAKER, MRI (US)
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 12829488
• MDR Text Key: 280893314
• Report Number: 2017865-2021-36974
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: PM1140
• Device Lot Number: P000103821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 11/17/2021
• Supplement Dates Manufacturer Received: 11/18/2021; 04/29/2022
• Supplement Dates FDA Received: 11/19/2021; 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1