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

Model Number 1488T

Device Problems Signal Artifact/Noise (1036); Failure to Interrogate (1332); Pacemaker Found in Back-Up Mode (1440); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock from Patient Lead(s) (3162)

Event Type  malfunction  

Event Description

Technical services received a call on (b)(6)2012.Caller reported lead safety switch on this ra lead.Bipolar and unipolar unable to get thresholds.Noise and logbook full of inappropriate atr's.Programming it vvir per pa.Being followed by dr.(b)(6) at (b)(6).Battery nearing replacement and lead revision will be made then.No additional information is available at this time, 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: 17536549
• MDR Text Key: 321424618
• Report Number: MW5143436
• 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: 08/10/2012

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: 1488T
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1