MAUDE Adverse Event Report: MEDTRONIC MILACA, INC. CARELINK; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 2490C

Device Problem Device Emits Odor (1425)

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

Event Date 12/05/2013

Event Type  malfunction  

Event Description

It was reported by the patient¿s spouse that the remote monitor started making a clicking noise and the smelled like wires were burning.They disconnected the monitor from the electrical outlet and the monitor was hot on the bottom.The patient¿s spouse was referred to the clinic for a replacement and is returning the monitor.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

Product event summary: analysis found corrosion at the power supply, phone cable damage and one missing rubber foot.The device would not power up with the returned power supply.A bench power test passed with a good power supply.(b)(4).

• Brand Name: CARELINK
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC MILACA, INC.; 900 sixth avenue ne; milaca MN 56353 372
• 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: 3615124
• MDR Text Key: 4170044
• Report Number: 2183613-2014-00158
• 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: Other,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2490C
• Device Catalogue Number: 2490C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/22/2014
• Initial Date FDA Received: 02/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 00080 YR