MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CURRENT DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	2107-36
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Codes	Syncope (1610); Dyspnea (1816)
Date of Event	11/11/2019
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
Related manufacturer reference number: 2938836-2019-16805.It was reported that the patient presented in the emergency department (ed) with near syncope and dyspnea.A merlin transmission was attempted without success.The device was unable to be interrogated.The patient stated being non-compliant for routine device follow-ups and noted the device vibrating approximately two years prior to this (b)(6) visit.The physician assumed this vibratory alert was for eri.During the generator change-out on a device suspected to be at eos, externalized conductors were observed on the riata lead via x-ray.The device was explanted and replaced.The rv lead was capped and replaced on (b)(6) 2019.The patient was stable throughout the procedure and remained stable post procedure.
Additional Manufacturer Narrative
The reported field event of interrogation failure was confirmed in the lab.A longevity calculation was performed using default parameters and showed that the battery depletion was normal.The device was tested on the bench and no anomalies were found.The cause of the communication failure was determined to be low battery voltage due to normal battery depletion.

• Brand Name: CURRENT DR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 9392667
• Report Number: 2938836-2019-16804
• Device Sequence Number: 19866140
• Product Code: LWS
• UDI-Device Identifier: 05414734502207
• UDI-Public: 05414734502207
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

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: 06/30/2008
• Device Model Number: 2107-36
• Device Catalogue Number: 2107-36
• Device Lot Number: 0002223168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 12/01/2019
• Supplement Report FDA Received Date: 03/27/2020
• 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: 44 YR