MAUDE Adverse Event Report: IPG MFG SWITZERLAND VITATRON DA+ C-SERIES DR; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

Model Number C60A2U

Device Problem Reset Problem (3019)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/07/2016

Event Type  Injury  

Manufacturer Narrative

Product event summary: the device was returned and analysis of the device memory indicated a partial electrical reset.It was noted a partial reset occurred on (b)(6) 2016.

Event Description

It was reported that implantable pulse generator (ipg) exhibited a power on reset (por).The device was interrogated, recovered all parameters and remains in use.No patient complications have been reported as a result of this event.

• Brand Name: VITATRON DA+ C-SERIES DR
• Type of Device: PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer (Section G): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5711450
• MDR Text Key: 47106993
• Report Number: 9614453-2016-03578
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P990001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/28/2008
• Device Model Number: C60A2U
• Device Catalogue Number: C60A2U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2007
• 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
• Patient Outcome(s): Required Intervention