MAUDE Adverse Event Report: MPRI ATTAIN STABILITY QUAD MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 479888

Device Problems Break (1069); Device Contamination with Body Fluid (2317); Deformation Due to Compressive Stress (2889); Activation, Positioning or Separation Problem (2906)

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

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the implant procedure, the physician was having difficulty moving the hybrid guidewire through the left ventricular (lv) lead.It was noted that the physician observed some kinking of the lead.The guidewire was removed, and a new guidewire was used, but the same problem was seen.It was noted that the physician has a feeling of ¿intern hardness of the electrode¿.The physician tried removing the guidewire but was not successful.The lead was removed, and blood was observed to be in the internal conductor of the lead.The physician thought it might be an internal break of the lead.The lead was not used, and another lead was implanted.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the full lead was returned and analyzed.Analysis indicated the distal conductor of the lead was obstructed due to a guidewire stuck in the lumen.The guidewire was kinked/buckled.There was blood on the distal conductor of the lead, and it was not obstructed.The tip seal on the distal electrode of the lead showed evidence of blood ingression.Visual analysis of the lead indicated damage at implant.The analyst noted by design, left heart leads are manufactured with a septum in the tip that will sometimes allow blood ingress.Visual inspection showed that guidewire tip kinked at the lead tip causing obstruction.Destructive analysis was performed, guidewire could be removed easily from the lead distal end and discovered it¿s not medtronic guidewire.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN STABILITY QUAD MRI SURESCAN
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 11066335
• MDR Text Key: 223436700
• Report Number: 2649622-2020-25281
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2022
• Device Model Number: 479888
• Device Catalogue Number: 479888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1