MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGENIO; PULSE-GENERATOR, SINGLE CHAMBER, SINGLE

Model Number J172

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2019

Event Type  malfunction  

Manufacturer Narrative

Following completion of analysis, a follow-up report will be completed.

Event Description

It was reported that during the attempted implant of this device, upon lead insertion, the pacing frequency was lower than the marked frequency.For this reason, the device was removed and returned for analysis.No resulting adverse patient effects.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.A visual inspection of the device header and case noted no anomalies.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

Event Description

It was reported that during the attempted implant of this device, upon lead insertion, the pacing frequency was lower than the marked frequency.For this reason, the device was removed and returned for analysis.No resulting adverse patient effects.

• Brand Name: INGENIO
• Type of Device: PULSE-GENERATOR, SINGLE CHAMBER, SINGLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8537569
• MDR Text Key: 142681913
• Report Number: 2124215-2019-07210
• Device Sequence Number: 1
• Product Code: LWW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2020
• Device Model Number: J172
• Device Catalogue Number: J172
• Device Lot Number: 296495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Date Manufacturer Received: 06/03/2019
• Patient Sequence Number: 1