MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO, MED REL KAPPA 900 DR; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

Model Number KDR901

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 511212 competitor lead, implanted on (b)(6) 2008, dtba1d1 crt-d, implanted: (b)(6) 2016.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by the patient that the implantable pulse generator (ipg) "which is now inactive has moved." the device was reported to have been inactivated approximately 10 years ago.Communication attempts were made with the clinic but were unsuccessful.No patient complications have been reported as a result of this event.

• Brand Name: KAPPA 900 DR
• Type of Device: PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7255421
• MDR Text Key: 99837713
• Report Number: 2647346-2018-00004
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/28/2004
• Device Model Number: KDR901
• Device Catalogue Number: KDR901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2017
• Date Device Manufactured: 06/03/2003
• 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 Age: 60 YR