MAUDE Adverse Event Report: ABBOTT SBP DR INDUCTIVE PACEMAKER, JPD; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM2152

Device Problems Over-Sensing (1438); Capturing Problem (2891); No Pacing (3268)

Patient Problems Dizziness (2194); Syncope/Fainting (4411)

Event Date 09/21/2022

Event Type  malfunction  

Event Description

During an in clinic follow up, the patient noted dizziness.Upon interrogation, a high threshold and episodes of oversensing due to crosstalk resulting in pacing inhibition were noted.Technical support was contacted and also noted oversensing due to crosstalk.Provocative testing was performed and the oversensing was unable to be reproduced.The device was reprogrammed to resolve the event.The patient was stable.

Event Description

Additional information was received indicating the noted syncope was not suspected to be related to the device.

Event Description

Additional information was received indicating the patient experienced an episode of syncope following the reprogramming of the device.No additional intervention has been performed at this time.The patient was stable and will continue to be monitored.

• Brand Name: SBP DR INDUCTIVE PACEMAKER, JPD
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15526335
• MDR Text Key: 306086655
• Report Number: 2017865-2022-40130
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2023

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: 09/30/2021
• Device Model Number: PM2152
• Device Lot Number: P000101310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/02/2022
• Supplement Dates Manufacturer Received: 12/15/2022; 01/06/2023
• Supplement Dates FDA Received: 01/04/2023; 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2020
• 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