MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FRONTIER II; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number 5596

Device Problems Failure to Interrogate (1332); Communication or Transmission Problem (2896)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the pulse generator could not be interrogated.The patient was in stable condition.No intervention or additional information was reported.

Event Description

New information reported that the device was explanted.No additional information was reported.

Event Description

New information reported on 05/18/16 stated that the reason for the explant was due to the inability to interrogate the device.The device was explanted sometime in (b)(6); the patient did not experience any symptoms.

Manufacturer Narrative

Device was in bvvi mode due to nmi after it was explanted.Exposure to cold temperature was likely the cause of the nmi.Product code was reloaded successfully but it could not establish communication with programmer.After installing new battery, device regained communication, but it would lose telemetry when voltage dropped below 2.37v.Analysis on hybrid showed that the combo ic u2 was causing the interrogation anomaly when voltage was at or near eri level.The combo ic was replaced and hybrid passed all tests.

• Brand Name: FRONTIER II
• 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: 5624809
• MDR Text Key: 44336204
• Report Number: 2017865-2016-02666
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2010
• Device Model Number: 5596
• Device Lot Number: 2914041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2009
• 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 Outcome(s): Required Intervention