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

Model Number	CD3211-36
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
Date of Event	05/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that the asymptomatic patient presented in clinic for follow-up.Upon interrogation, it was noted that the implantable cardioverter defibrillator was in backup vvi.It was also noted that the patient may have received inappropriate high voltage therapy but they were unable to confirm it due to the low battery status of the device.A device download could not be performed due to the low battery status.On (b)(6) 2018, the device was explanted and replaced due to normal elective replacement indicator.Patient was in good condition throughout.

• Brand Name: PROMOTE PLUS CRT-D
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 7597179
• Report Number: 2017865-2018-08734
• Device Sequence Number: 13503894
• Product Code: NIK
• UDI-Device Identifier: 05414734503693
• UDI-Public: 05414734503693
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/13/2018

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: 09/30/2011
• Device Model Number: CD3211-36
• Device Lot Number: 3091651
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/13/2018
• 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