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

Model Number	2107-36
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2018
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 device could not be interrogated.No communication could be established.It was noted that patient has frequent ventricular tachycardia with multiple discharge therapy resulting in battery depletion.The device was explanted and replaced.Patient was stable.
Additional Manufacturer Narrative
The reported inability to communicate with the device was confirmed in the laboratory due to premature battery depletion.The battery was observed to be swollen and fully depleted.A longevity calculation was performed and showed that the battery depleted prematurely.The device was tested on the bench and no anomalies were found.The cause of the reported field event was isolated to an internal anomaly in the battery.

• 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: 8110945
• Report Number: 2938836-2018-12543
• Device Sequence Number: 2165760
• 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: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2019

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: 02/29/2016
• Device Model Number: 2107-36
• Device Lot Number: 4778042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 10/29/2019
• 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: Required Intervention
• Patient Age: 82 YR
• Patient Weight: 80