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

Model Number PM2240

Device Problem Migration (4003)

Patient Problems Bradycardia (1751); Twiddlers Syndrome (2114)

Event Date 01/02/2020

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

Related manufacturer reference number: 2017865-2020-00725.Related manufacturer reference number: 2017865-2020-00726.It was reported that the patient presented in the emergency room with bradycardia.An x-ray was performed and revealed that the right atrial and right ventricular leads had dislodged due to twiddlers syndrome.The leads were explanted.The right ventricular lead was replaced.The pulse generator had migrated and was repositioned on (b)(6) 2020.The patient was in stable condition post-procedure.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 9613029
• MDR Text Key: 175828751
• Report Number: 2017865-2020-00723
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507073
• UDI-Public: 05414734507073
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/21/2020

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: 12/31/2019
• Device Model Number: PM2240
• Device Catalogue Number: PM2240
• Device Lot Number: A000059986
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/02/2020
• Initial Date FDA Received: 01/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 96 YR