MAUDE Adverse Event Report: CPI - DEL CARIBE INGEVITY; IMPLANTABLE LEAD

Model Number 7741

Device Problems Difficult To Position (1467); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problems Atrial Fibrillation (1729); Low Blood Pressure/ Hypotension (1914)

Event Date 05/06/2017

Event Type  Injury  

Manufacturer Narrative

This lead has been returned for analysis.This report will be updated upon completion of analysis.

Event Description

Boston scientific received information that during the attempted implant of this right atrial (ra) lead, placement difficulty was noted and the lead dislodged.During the repositioning attempt, the helix was stuck in an extended position and the helix was unable to be retracted after more than 30 turns.The patient was noted to be very fragile, and had a severe drop in their blood pressure.Intravenous medications were administered at that time.Due to the unstable blood pressure, the physician elected to abort the atrial lead implant.The patient also developed paroxysmal atrial fibrillation (af) with slow ventricular response/atrioventricular block.The lead was returned for analysis.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, visual inspection noted the helix was extended and dried blood/tissue was present around the helix.Resistance testing found the lead was not electrically continuous.Detailed analysis confirmed that the inner conductor coil had a break at the distal end of the terminal pin.Based upon the clinical observations and the laboratory findings, we believe that torsional overstress during attempts to extend/retract the helix caused the inner conductor coil to break.

• Brand Name: INGEVITY
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 6701117
• MDR Text Key: 79622650
• Report Number: 2124215-2017-08685
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 00802526523458
• UDI-Public: (01)00802526523458(17)20190313
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2019
• Device Model Number: 7741
• Other Device ID Number: INGEVITY MRI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2017
• 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
• Treatment: 7740; 7741; 7742; L311
• Patient Outcome(s): Life Threatening; Required Intervention; Disability
• Patient Age: 83 YR