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

Model Number 7742

Device Problems Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2015

Event Type  malfunction  

Event Description

Boston scientific received information that this right ventricular (rv) lead was not successfully implanted due to repeated dislodgments during the implant procedure.Helix mechanism eventually became non-functional.No adverse patient effects were reported.

Manufacturer Narrative

(b)(4).Upon receipt at our post market quality assurance laboratory, visual inspection noted the helix was retracted and dried blood was present in the helix housing.Resistance testing found the lead was not electrically continuous.Detailed analysis confirmed that the cathode conductor coil was fractured at the distal end of the terminal pin.Microscopic analysis confirmed that the lead became fractured due to torsional overstress.A laboratory technician tested the helix mechanism and found it was nonfunctional, confirming the clinical observation.Based upon the clinical observations and the laboratory findings, we believe the conductor coil became fractured during attempts to extend/retract the helix.

Manufacturer Narrative

(b)(4).Additional analysis was performed on this lead.An x-ray of the lead confirmed that the inner conductor coils are continuous however they are bunched down just distal to the terminal pin.Repeat continuity testing confirmed this.Dried blood/body fluids were observed in the helix housing.A laboratory technician tested the helix mechanism and found it was nonfunctional, confirming the clinical observation.There was nothing wrong with the lead tip that would have contributed to the dislodgement.Based upon the clinical observations and the laboratory findings, we believe that body fluids inside the helix housing caused the irregularity in helix function.

• 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN 55112 ; 6515824786
• MDR Report Key: 4885178
• MDR Text Key: 19734180
• Report Number: 2124215-2015-07868
• Device Sequence Number: 1
• Product Code: DTD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2017
• Device Model Number: 7742
• Other Device ID Number: INGEVITY MRI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2015
• 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: K285
• Patient Age: 79 YR