MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. IDENTITY ADX SR; IMPLANTABLE PULSE GENERATOR, PACEMAKER

Model Number 7548159

Device Problems High impedance (1291); Connection Problem (2900); Positioning Problem (3009)

Patient Problem Failure of Implant (1924)

Event Date 05/11/2015

Event Type  malfunction  

Event Description

Following a pacemaker generator change out, it was noticed by the st.Jude rep that the pacemaker was not pacing.It was determined by x-ray that the ventricular lead was not placed (screwed) in the generator correctly.We had to re-prep the patient, set up for another procedure and reopen the pocket to screw the lead into the generator.This caused prolonged case.After closing the pocket when the pacemaker was being re-interrogated, it was found that the ventricular lead had a very high impedance and further evaluation revealed that the pin connecting the lead to the generator was not making contact.At this point, the pacemaker company representative mentioned that some pacemakers may have been coming from the factory with the "pin" clamping screw not set correctly.After some discussion, the pocket was reopened and that turned out to be the case.The pin was adjusted and re-tightened.Thereafter, excellent measurements were obtained.The generator was replaced in the pocket, irrigated again with several hundred cc's of triple antibiotic solution and closed.Manufacturer response for pacemaker generator, st.Jude 5386 (per site reporter).Rep on site.

• Brand Name: IDENTITY ADX SR
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: jaime chavez ; 15900 valley view ct.; sylmar, CA 91342
• MDR Report Key: 5010419
• MDR Text Key: 23268171
• Report Number: 5010419
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 07/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 7548159
• Device Catalogue Number: 5386
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78 YR