MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) DURATA STS OPTIM PASSIVE FIXATION; DEFIBRILLATION LEAD

Model Number 7170/65

Device Problems Break (1069); High impedance (1291); Over-Sensing (1438); Inappropriate or Unexpected Reset (2959)

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

Event Date 09/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when a patient presented in-clinic after receiving vibratory alerts, the device was found to be in backup-vvi mode.It was noted that the backup was due to extensive charging caused by lead noise.High, out of range pacing lead impedance and lead damage were also observed.The patient was stable.A system replacement was suggested.

Event Description

New information received indicates that the lead was explanted and replaced.The patient was okay post-procedure.

Manufacturer Narrative

A partial lead with the connector pin measuring 56.7cm was returned in two segments for analysis.The damage found was sustained during the surgical procedure.The portion of the lead that was returned was otherwise normal.

• Brand Name: DURATA STS OPTIM PASSIVE FIXATION
• Type of Device: DEFIBRILLATION LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6050777
• MDR Text Key: 58524615
• Report Number: 2938836-2016-13216
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P950022
• 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: 09/30/2016

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: 05/31/2016
• Device Model Number: 7170/65
• Device Lot Number: 4081226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2016
• Initial Date FDA Received: 10/24/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/28/2016; 01/12/2017; 01/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2013
• 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
• Treatment: (B)(4)
• Patient Outcome(s): Required Intervention