MAUDE Adverse Event Report: ABBOTT CURRENT PLUS VR, DF-4 CONNECTOR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	CD1211-36Q
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a follow up in clinic, the device was found with battery voltage at elective replacement indicator (eri) level.The physician suspected longevity overestimation occurred at the previous follow up in clinic.The device was explanted and replaced due to normal eri.No intervention was required.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of overestimation was confirmed.The device was below elective replacement indicator (eri) upon receipt.Longevity analysis found the battery depletion to be normal.The device functioned normally during analysis.No anomalies were found.The longevity overestimation was determined to be due to an estimation inaccuracy in the merlin programmer remaining longevity calculation.

• Brand Name: CURRENT PLUS VR, DF-4 CONNECTOR
• 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: 20529692
• Report Number: 2017865-2024-68177
• Device Sequence Number: 9117792
• Product Code: NVZ
• UDI-Device Identifier: 05414734503716
• UDI-Public: (01)05414734503716(10)S000010496(17)170228
• 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: 2016
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: CD1211-36Q
• Device Lot Number: S000010496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/14/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2015
• 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
• Patient Sex: Unknown