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

Model Number C60A2U

Device Problems Device Sensing Problem (2917); Reset Problem (3019)

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

Event Date 02/17/2014

Event Type  Injury  

Event Description

It was reported that during the device follow up, the sensing and the threshold was unable to be measured.It was further reported that a device power on reset (por) had occurred and a manual guided restore (mgr) is required to be performed on the device by a trained individual.The device remains in use.No patient complications have been reported as a result of this event.

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: 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): MEDTRONIC CARDIAC RHYTHM DISEASE MGMT; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: nashoane fulwood-kelley ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635260583
• MDR Report Key: 3743314
• MDR Text Key: 4422137
• Report Number: 9614453-2014-00726
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• 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: C60A2U
• Device Catalogue Number: C60A2U
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2014
• Date Device Manufactured: 08/21/2007
• 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
• Patient Age: 00065 YR