MAUDE Adverse Event Report: HISTORICAL CPI ST. PAUL TRANSVENOUS; IMPLANTABLE LEAD

Model Number 4260

Device Problems Low impedance (2285); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2016

Event Type  malfunction  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that when doing a routine device change out procedure the setscrew of this device was loosened and the right ventricular (rv) lead was attempted to be removed from the device, but it was not possible to remove the lead.Mineral oil was used but the lead was still not removed.The physician attempted to pull the lead from the proximal side and the lead pin almost came off.The rv lead impedance measurements were low and out of range when measuring the lead with a pacing system analyzer (psa) and through the device.A new rv lead was connected to the new device and the procedure was completed.No adverse patient effects were reported.The device and lead will not be returned.

• Brand Name: TRANSVENOUS
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): HISTORICAL CPI ST. PAUL; guidant corporation; saint paul MN
• Manufacturer (Section G): HISTORICAL CPI ST. PAUL; guidant corporation; saint paul MN
• Manufacturer Contact: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5823862
• MDR Text Key: 51174795
• Report Number: 2124215-2016-07283
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• PMA/PMN Number: K822458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/12/1992
• Device Model Number: 4260
• Other Device ID Number: ---
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 97 YR