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

Model Number 1646T/58

Device Problems Break (1069); Kinked (1339)

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

Event Date 10/17/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a routine device changeout procedure, an insulation abrasion was observed on the right ventricular lead.Migration of the pulse generator had also caused a kink in the lead.An increase in capture threshold was noted as well.The lead was capped and replaced during the changeout procedure.

Manufacturer Narrative

(b)(4).Final analysis found that the insulation was abraded at 16.9cm to 17.3cm from the connector pin, which exposed the outer coil.The abrasion was consistent with exposure to constant friction against another implantable device.A kink was found at 2.5cm from the connector pin.The damage found likely resulted in the reported capture anomaly.

• Brand Name: ISOFLEX S 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: 5189527
• MDR Text Key: 29956643
• Report Number: 2017865-2015-29697
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2010
• Device Model Number: 1646T/58
• Device Lot Number: 0002141705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2007
• 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