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

Model Number PM3112

Device Problem Incorrect Measurement (1383)

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

Event Date 02/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Upon interrogation, the device showed false eri resulting in explant and replacement.The patient is in stable condition.

Manufacturer Narrative

The complaint of early battery depletion could not be confirmed.The device was received in normal working condition, with battery voltage above eri level.Analysis indicated a false eri trip has occurred, and the date shown as (b)(4) 2013 which is before the manufacturing date.False eri trip could happen when the device exposed to strong emi.In those cases, clearing the eri message with the programmer restores normal function.Electrical and mechanical tests indicated that the device exhibited normal characteristics with no anomalies.

• Brand Name: ANTHEM CRT-P
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6440656
• MDR Text Key: 71092463
• Report Number: 2017865-2017-01841
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030035
• 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
• Report Date: 05/26/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: PM3112
• Device Lot Number: 4306290
• Other Device ID Number: 05414734502832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2017
• Initial Date FDA Received: 03/28/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2013
• 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): Hospitalization; Required Intervention