MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (CRM-KISTA) ENDURITY MRI PACEMAKER, SR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM1172

Device Problem Loss of Data (2903)

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

Event Date 11/04/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the pulse generator had exhibited a diagnostics anomaly.All other functions were normal.No changes were made.

Manufacturer Narrative

Correction/retraction: upon review of mdr-3010215456-2015-32867 which was submitted on 12/19/2015, it was determined that this event should not have been reported as an mdr as model pm1172 mri pulse generator is not fda approved and is not similar to a device that is currently fda approved.All previously reported information should be nulled and voided.

• Brand Name: ENDURITY MRI PACEMAKER, SR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CRM-KISTA); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (CRM-KISTA); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: ulla strindlund ; box 7051; isafjordsgatan 15; kista SE-16-407 ; SW SE-16407 ; 4684744043
• MDR Report Key: 5312677
• MDR Text Key: 34575705
• Report Number: 3010215456-2015-32867
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 11/04/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: PM1172
• Device Lot Number: P000011775
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2015
• Initial Date FDA Received: 12/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2015
• 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: 76 YR