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

Model Number C60A2U

Device Problems Failure to Interrogate (1332); Nonstandard Device (1420); Reset Problem (3019)

Patient Problem Syncope (1610)

Event Date 05/06/2012

Event Type  Injury  

Event Description

It was reported that an electrical reset occurred with the device.The device operated in back-up mode and could not be interrogated.No stimulation occurred and the patient experienced fainting.The device reached elective replacement indicator (eri) and was scheduled for replacement.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

This model number is not approved for distribution in the united states, however, it is similar to a device marketed in the u.S.The event is being reported due to an alleged malfunction.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Analysis revealed the returned device indicated normal battery depletion.The returned device indicated a firmware error message/code.

Manufacturer Narrative

Product event summary: analysis of the device memory indicated a partial electrical reset.Partial reset occurred on (b)(6) 2012.This device was included in that field action, but returned product testing found the device did not perform as described in the field action.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 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: 3990423
• MDR Text Key: 4958361
• Report Number: 9614453-2014-01795
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P990001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/28/2007
• Device Model Number: C60A2U
• Device Catalogue Number: C60A2U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0999-2007
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention