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

Model Number	3207-30
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2018
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 patient presented for a generator change as the device has been end of life (eol) for couple of years.The physician noted that the device was bulged and suspected that the battery was swollen or the can was leaking inside.The device was explanted and replaced.The patient was discharged.
Additional Manufacturer Narrative
The reported field event of swollen device was verified in the lab.It was noted that the device was post end of life (eol) and swollen battery is consistent with post end of life (eol) and would not be considered abnormal.A longevity calculation was performed using default settings and found the battery depletion was normal.No source of high current was observed.The device was tested at the bench and no anomalies were found.
Event or Problem Description
New information received states that the patient condition was stable post procedure.

• Brand Name: PROMOTE RF CRT-D
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 8012582
• Report Number: 2938836-2018-11566
• Device Sequence Number: 16459438
• Product Code: NIK
• UDI-Device Identifier: 05414734502252
• UDI-Public: 05414734502252
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2019

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: 11/30/2009
• Device Model Number: 3207-30
• Device Lot Number: 2731641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 09/17/2019; 09/26/2019
• Initial Report FDA Received Date: 10/28/2018
• Supplement Report FDA Received Date: 09/25/2019; 10/01/2019
• 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: 77 YR