MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. PROMOTE PLUS CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD1233-40Q
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During a follow-up in clinic, there was an unexpected decrease in remaining longevity of the device.Premature battery depletion was suspected.Device replacement is anticipated and the patient was stable with no consequences.
Additional Manufacturer Narrative
The device is included in the premature battery depletion with implantable cardioverter defibrillator advisory notice issued by st.Jude medical on 11 october 2016.
Event or Problem Description
Additional information received indicated that the device could not be interrogated.The device was explanted and the patient was stable following the procedure.
Additional Manufacturer Narrative
Premature battery depletion was confirmed by analysis.A device evaluation was performed, and no sources of high current were noted.The cause of the premature battery depletion was consistent with li cluster formation.From these analyses, in the absence of high current draw, it is probable that the premature battery depletion was caused by a lithium cluster induced short circuit.Li clusters are a known depletion mechanism for these advisory products that has been investigated and associated with a field action in october 2016.

• Brand Name: PROMOTE PLUS CRT-D
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 7873610
• Report Number: 2938836-2018-10599
• Device Sequence Number: 1190879
• Product Code: LWS
• UDI-Device Identifier: 05414734503693
• UDI-Public: 05414734503693
• 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: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/24/2019

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: 07/31/2013
• Device Model Number: CD1233-40Q
• Device Lot Number: 3610270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 10/23/2018; 11/14/2018; 01/22/2019
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 10/25/2018; 11/16/2018; 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0115-2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention