MAUDE Adverse Event Report: OSCOR, INC. PACEMAKER LEAD ADAPTOR

Model Number BIS/IS-15

Device Problems High Sensing Threshold (2574); Impedance Problem (2950)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Allegations of high thresholds and lead impedance warning.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PACEMAKER LEAD ADAPTOR
• Type of Device: PACEMAKER LEAD ADAPTOR
• Manufacturer (Section D): OSCOR, INC.
• MDR Report Key: 17489898
• MDR Text Key: 320697115
• Report Number: MW5122416
• Device Sequence Number: 1
• Product Code: DTD
• 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: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: BIS/IS-15
• Patient Sequence Number: 1