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

Model Number	2107-36
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results will be provided in the final report.
Event or Problem Description
It was reported that the device was found to be in backup vvi.The device was explanted and replaced.The patient was stable after the procedure.
Additional Manufacturer Narrative
The reported event of backup vvi was confirmed.The device was found to be in backup vvi when received.The reason of backup vvi was due to power on reset (por) which occurred due to high voltage therapy.The cause of por could not be determined.Additional information: d10.

• 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: 8606326
• Report Number: 2938836-2019-03400
• Device Sequence Number: 2319214
• Product Code: LWS
• UDI-Device Identifier: 05414734502207
• UDI-Public: 05414734502207
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2020

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: 02/29/2016
• Device Model Number: 2107-36
• Device Catalogue Number: 2107-36
• Device Lot Number: 4778042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/27/2019
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 07/27/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 78 YR