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

Model Number 7742

Device Problems Failure to Capture (1081); High impedance (1291); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2015

Event Type  Injury  

Event Description

Boston scientific received information that during a routine follow-up, this right ventricular (rv) lead exhibited increased pacing threshold measurements, to 5.0v.The pacing impedance measurements were also trending upward, but remained within range.A microdislodgement was suspected and the patient was scheduled for a lead repositioning.During the revision procedure, unusual electrograms (egms) were observed during lead testing.Several positions were attempted, then the helix became stuck and the lead could no longer be used.The lead was removed and another lead of the same model was implanted successfully.No additional adverse patient effects were reported.

Event Description

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Manufacturer Narrative

(b)(4).The electrograms from the revision procedure were not provided to boston scientific for review.The explanted lead is expected to be returned for analysis.This report will be updated upon return and completion of analysis.

Manufacturer Narrative

(b)(4).Upon receipt at our post market quality assurance laboratory, visual inspection noted the helix was stretched, with dried blood observed 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 during the revision procedure.

• 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: 4883548
• MDR Text Key: 6023326
• Report Number: 2124215-2015-06439
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/08/2015

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/22/2016
• Device Model Number: 7742
• Other Device ID Number: INGEVITY MRI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2014
• 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: 7742; 7741; K287
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 91 YR