MAUDE Adverse Event Report: ABBOTT CURRENT+ DR DUAL-CHAMBER ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD2211-36
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results, method, and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During an in clinic follow-up, the device was interrogated and revealed high, out of range impedance on the right ventricular channel.Prior to the revision procedure, interrogation revealed that the impedance values had stabilized and all other electrical value were stable and in range.It was suspected that the impedance anomaly was due to the connection between the lead and device header.The device was explanted and replaced to resolve the event and the patient was stable.
Additional Manufacturer Narrative
Additional information: d10, h3, and h6.The reported event of high ventricular pacing lead impedance (v-pli) was confirmed by analysis.The device programmer printouts showed high v-pli within the last ten days before the device was explanted.The device telemetry, pacing, sensing, impedance, high voltage shock output, and patient notifier were tested on the bench.No anomalies were detected.The anomaly observed in the field could not be replicated in the lab.

• Brand Name: CURRENT+ DR DUAL-CHAMBER ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10478232
• Report Number: 2938836-2020-08114
• Device Sequence Number: 2880398
• Product Code: NVZ
• UDI-Device Identifier: 05414734503723
• UDI-Public: 05414734503723
• 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
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: CD2211-36
• Device Catalogue Number: CD2211-36
• Device Lot Number: 4908041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 120