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

Model Number 1888TC/52

Device Problems Break (1069); Pacing Intermittently (1443)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2021

Event Type  Injury  

Event Description

It was reported the patient presented remotely.Upon review of merlin.Net transmissions, it was observed the patient's right ventricular was pacing intermittently.A clavicle crush was suspected.The lead was extracted on (b)(6) 2021.It was observed the insulated had come off of the header portion of the lead.The lead was in stable condition.

Manufacturer Narrative

The reported events of clavicle crush, insulation abrasion, impedance issue, and failure to capture were not confirmed.As received, a complete lead was returned in multiple pieces.Visual inspection of the lead found damaged consistent with occurring at time of procedure.Electrical testing did not find any indication of conductor fractures or internal shorts.All damage noted to lead was consistent with occurring at time of procedure.

• Brand Name: TENDRIL ST
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11931958
• MDR Text Key: 254073792
• Report Number: 2017865-2021-20305
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734501750
• UDI-Public: 05414734501750
• Combination Product (y/n): Y
• PMA/PMN Number: P960013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: 1888TC/52
• Device Catalogue Number: 1888TC-52
• Device Lot Number: 4800326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention