MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ISOFLEX OPTIM LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 1948/58

Device Problems Intermittent Capture (1080); Kinked (1339); Low impedance (2285)

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

Event Date 11/08/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the right ventricular lead exhibited intermittent capture and had a low impedance.It was noted that the lead was kinked.The lead was not used.

Manufacturer Narrative

The field report of stimulated intermittent, low impedance and lead bent were confirmed.Final analysis found an indication of an internal short due to the inner insulation damaged at the proximal region caused by the compressed outer coil at 10.8 cm and 20.5 cm from the connector region.

• Brand Name: ISOFLEX OPTIM LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: 5240291
• MDR Text Key: 31887100
• Report Number: 2017865-2015-30325
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P960030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: 1948/58
• Device Lot Number: P000007726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2015
• 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: 60 YR
• Patient Weight: 80