ST JUDE MEDICAL NEUROMODULATION UNIT 1/25 3850

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-08-06 for ST JUDE MEDICAL NEUROMODULATION UNIT 1/25 3850 manufactured by St Jude Medical.

Event Text Entries

[2735360] The neuromodulation unit that was implanted on (b)(6) 2011 stopped emitting electrical impulses. The battery lost all power. It was from st. Jude medical co. Model #3850ans. The unit had to be surgically removed and replaced on (b)(6) 2011. The battery should have had an operational life of up to three-3-years. We were told the battery came from a different supplier as the normal battery was produced in the section of (b)(6) that suffered from the (b)(6) and the plant was closed. The unit that was used for replacement was about a third larger and is to have an output life of over five-5-years. It is also an ans unit from the same company. We are experiencing a power loss problem with this unit. It has shut itself down once and continues to issue a "low battery" warning and to contact our physician. The st jude clinical specialist ensures us that the unit will continue to function with power. We are checking the battery twice a week to verify the unit continues to function with electrical output. Dates of use: (b)(6) 2011 - (b)(6) 2012. Reason for use: neuromodulation unit for chronic pain.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5026431
• MDR Report Key: 2689904
• Date Received: 2012-08-06
• Date of Report: 2012-08-06
• Date of Event: 2012-03-14
• Date Added to Maude: 2012-08-13
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ST JUDE MEDICAL NEUROMODULATION UNIT 1/25
• Generic Name: NEUROMODULATOR
• Product Code: LCW
• Date Received: 2012-08-06
• Returned To Mfg: 2012-03-22
• Model Number: 3850
• Catalog Number: 3850
• Lot Number: 3850ANS
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ST JUDE MEDICAL
• Manufacturer Address: PLANO TX 75024 US 75024

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2012-08-06