MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGEVITY MRI; IMPLANTABLE LEAD

Model Number 7740

Device Problems Device Dislodged or Dislocated (2923); Device Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978)

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

Event Date 10/10/2018

Event Type  Injury  

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

Event Description

It was reported that this right atrial (ra) lead along with the right ventricular (rv) lead dislodged.A revision procedure was performed.During an attempt to reposition the ra lead, difficulty was encountered with retracting the helix.The ra lead was explanted and replaced.Visual inspection after explant noted tissue in the helix mechanism.The rv lead was successfully repositioned.The physician suspected potential arm movement may have been a factor in the dislodgement.No additional adverse patient effects were reported.

• Brand Name: INGEVITY MRI
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): GUIDANT PUERTO RICO, B.V.; no. 12, road 698; ,; dorado PR 00646 3311
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8084483
• MDR Text Key: 127569060
• Report Number: 2124215-2018-60627
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 00802526523427
• UDI-Public: 00802526523427
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P150012/S000
• 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
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/27/2020
• Device Model Number: 7740
• Device Catalogue Number: 7740
• Device Lot Number: 709405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 85 YR