MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ANTHEM RF CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM3210

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient presented at the hospital for reasons unrelated to the pacemaker.The device was checked exhibited -elective replacement indicator had been reached on (b)(6) 2016 and -end of service- had been reached on (b)(6) 2016, no capture was also noted with maximum output.There were no patient symptoms reported.

Manufacturer Narrative

The reported complaint of shortened eri to eos interval was confirmed.Device was received with no output and no telemetry due to low battery level.After replacing the battery and recovering the device to its normal operating mode, all tests performed indicated normal device functionality.Field information was requested regarding explant date and session records, but no supporting information was available at the time of this analysis.Longevity assessment was performed based on nominal settings, indicating that implant duration of 6.5 years did not meet the total projected longevity of 8.59 years.Assessment of eri to eol duration indicated that device did not meet the expected interval of 4.4 months, as the eos level was reached one day after eri was triggered.A conductive bridge had formed between the anode and cathode separators of the battery, consistent with the reported issue of shortened eri to eos interval, which depleted the battery prematurely.

Event Description

The device was explanted due to unknown reason.

• Brand Name: ANTHEM RF CRT-P
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: jaime chavez ; 15900 valley view court; sylmar, CA 91342 ; 8184934022
• MDR Report Key: 5990946
• MDR Text Key: 56463668
• Report Number: 2017865-2016-06319
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2011
• Device Model Number: PM3210
• Device Lot Number: 2864284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR