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

Model Number 7742

Device Problems High impedance (1291); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4); the product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.

Event Description

Boston scientific received information that this right atrial (ra) lead exhibited high out-of-range impedances.A lead dislodgement was confirmed.Attempts to reposition were unsuccessful due to helix issues.No adverse patient effects were reported.The lead was explanted.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, visual inspection noted the helix was extended 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.Based upon the clinical observations and the laboratory findings, we believe the conductor coil became fractured during attempts to extend/retract the helix.

Event Description

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• 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 ; 6515824786
• MDR Report Key: 5211694
• MDR Text Key: 30801029
• Report Number: 2124215-2015-13619
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/21/2017
• Device Model Number: 7742
• Other Device ID Number: INGEVITY MRI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2015
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention