MAUDE Adverse Event Report: IPG MFG SWITZERLAND SIGMA 300 DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number SDR303U

Device Problem Pacing Problem (1439)

Patient Problem Death (1802)

Event Date 11/15/2014

Event Type  Death  

Event Description

It was reported that approximately 30 minutes after passing through an airport scanner, the patient felt dizzy and collapsed and subsequently died.A cause of death was unknown.It was reported that there was a possible malfunction of the device after interaction with a metal detector.There was no allegation from a health care professional that the implantable pulse generator (ipg) system was related to the death of the patient.No additional information was provided.

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).

• Brand Name: SIGMA 300 DR
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4357813
• MDR Text Key: 5118768
• Report Number: 9614453-2014-03120
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: P980035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/14/2009
• Device Model Number: SDR303U
• Device Catalogue Number: SDR303U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 12/23/2014
• Date Device Manufactured: 08/16/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN LEAD, UNKNOWN LEAD
• Patient Outcome(s): Death
• Patient Age: 00030 YR