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

Model Number	CD3215-36
Medical Device Problem Codes	Premature Discharge of Battery (1057); Data Problem (3196)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2018
Type of Reportable Event	Malfunction
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 during clinic follow-up, device interrogation showed the battery status less than 3 months to eri.It was noted the remaining longevity of the battery was estimated to be 2.2 years in previous interrogation in (b)(6) 2018.Early battery depletion was suspected.The patient is in stable condition.An intense 1-month follow-up was discussed.
Additional Manufacturer Narrative
Correction: (b)(4).
Event or Problem Description
New information indicated that inaccurate estimation of longevity was noted on the device.There was no premature battery depletion as previously reported.The device was later explanted on (b)(6) 2018.Patient was stable.

• Brand Name: PROMOTE ACCEL ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 7830228
• Report Number: 2938836-2018-10107
• Device Sequence Number: 2336185
• Product Code: NIK
• UDI-Device Identifier: 05414734502566
• UDI-Public: 05414734502566
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2012
• Device Model Number: CD3215-36
• Device Catalogue Number: CD3215-36
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1