MAUDE Adverse Event Report: PACESETTER PULSE-GENERATOR, PERMANENT, IMPLANTABLE; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 1688TC

Device Problems Failure to Capture (1081); High impedance (1291); High Capture Threshold (3266)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This rv lead was implanted on (b)(6) 2004.A call to technical services on us (b)(6) 2012 states that patient fell yesterday and hurt his shoulder.Today they saw loss of capture on telemetry.Rv threshold was 1.1 v at 0.5ms and now is 2.9 v at 1 ms, put at max output.Patient has complete heart block.Pauses were "short", caller states less than 1 second.Unable to measure impedances.Likely noise on leads prevented impedance measurements.Technical services suggested fluoro of system before opening pocket ~ scheduled for tomorrow.Patient is in the hospital.Update on (b)(6) 2012 states that lead impedances were 400 and 500 ohms/ threshold high in v at 2.5v at 1 ms/ decided to keep leads in and programmed output in the v to 5v and 1 / normal impedances through the device.The physician was dr.(b)(6) at (b)(6) hospital.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PULSE-GENERATOR, PERMANENT, IMPLANTABLE
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): PACESETTER
• MDR Report Key: 17529935
• MDR Text Key: 321350991
• Report Number: MW5136859
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2012

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?: No
• Device Model Number: 1688TC
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1