MAUDE Adverse Event Report: ABBOTT CURRENT PLUS VR; Pulse generator, permanent, implantable

Model Number	CD1211-36
Medical Device Problem Codes	Incorrect Interpretation of Signal (1543); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During an in-clinic follow-up, episodes of atrial fibrillation (af) were observed on the device.The af was incorrectly interpreted by the device which resulted in delivery of inappropriate shock.Abbott technical support was contacted, and the device was reprogrammed to avoid any future episodes of inappropriate shock.The patient was in stable condition.

• Brand Name: CURRENT PLUS VR
• Common Device Name: Pulse generator, permanent, implantable
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 20734942
• Report Number: 2017865-2024-70452
• Device Sequence Number: 15615679
• Product Code: NVZ
• UDI-Device Identifier: 05414734503686
• UDI-Public: (01)05414734503686(10)4745341(17)160229
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2016
• Device Model Number: CD1211-36
• Device Lot Number: 4745341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown