MAUDE Adverse Event Report: MEDTRONIC, INC. CARELINK; PROGRAMMER, PACEMAKER

Model Number 2090

Device Problems Incorrect Measurement (1383); Unable to Obtain Readings (1516)

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

Event Date 03/22/2013

Event Type  Injury  

Event Description

It was reported that the programmer was set to not "clip signals," however, the signals still seemed to be clipped.Follow up was conducted and found that reprogramming was done.The status of the programmer is unknown, but appears to be still 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.Without a lot number or device serial number, the manufacturing date cannot be determined.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.Product id: 5076-58 lead, implanted: (b)(6) 2013; product id: 6947m62 lead, implanted: (b)(6) 2013; product id: 429888 lead, implanted: (b)(6) 2013.

• Brand Name: CARELINK
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• 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: 3739693
• MDR Text Key: 17568377
• Report Number: 2182208-2014-00941
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2090
• Device Catalogue Number: 2090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/16/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DTBA2QQ
• Patient Outcome(s): Required Intervention
• Patient Age: 00074 YR
• Patient Weight: 112