MAUDE Adverse Event Report: GUIDANT PUERTO RICO BV

Model Number BRADY LEAD

Device Problems Failure to Capture (1081); High impedance (1291); Failure to Sense (1559); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2017

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 one day post-implant this pacemaker and right atrial (ra) lead exhibited high out-of-range pace impedance measurements and loss of capture (loc) with only some sensing observed in unipolar configuration.The lead was believed to be underinserted and it was recommended that a procedure be performed to reinsert the lead.The physician elected to not revise the lead and instead program the patient's device to right ventricular therapy only.No adverse patient effects were reported.This system remains in service.

• Manufacturer (Section D): GUIDANT PUERTO RICO BV
• Manufacturer (Section G): GUIDANT PUERTO RICO BV
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 6618830
• MDR Text Key: 77284260
• Report Number: 2124215-2017-07580
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: N/A
• 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: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BRADY LEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/24/2017
• Initial Date FDA Received: 06/07/2017
• 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