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

Model Number 350973

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); 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 ra lead is far field over sensing vp.There have been many atrs stored.This has been going on a long time.Discussed changing from nominal to least and asked what is cross changer blanking.A-blank after vp is 85.Technical services asked caller to extend this.Caller placed to 105 and still seeing over sensing.Had caller extend to 125msec.Still seeing artifact on egm.Caller able to mitigate issue with re-programming.Technical services stated to make sure to clear the counter to make sure there are no further atrs.No additional information is available at this time.Lead remains in service.Lead was implanted on (b)(6) 2007.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): BIOTRONIK
• MDR Report Key: 17536738
• MDR Text Key: 321171204
• Report Number: MW5143622
• 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: 350973
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1