MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SOLETRA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 7426

Device Problems Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Fatigue (1849); Nausea (1970); Complaint, Ill-Defined (2331); Malaise (2359); Electric Shock (2554)

Event Type  malfunction  

Event Description

It was reported that the patient felt like she was electrocuted from the deep brain stimulator since implant.The patient¿s healthcare professional was going to reduce the stimulation and eventually turn it off.When the patient had gone to see their healthcare professional he said that the device was already turned off.The patient felt like she was being electrocuted several times a day.The device was turned on and the patient could see lights, like the northern lights.The patient wanted the device turned off.The patient had been sick and nauseous lately.The patient had also been really tired lately, more tired than usual.No intervention or outcome was provided.Further follow-up is being conducted to obtain this information.If additional information is received a supplemental report will be submitted.Reference manufacturer¿s report number: 3004209178-2015-05881.

Manufacturer Narrative

Concomitant medical products: product id: 7426, serial# (b)(4), implanted: (b)(6) 2005, product type: implantable neurostimulator.Product id: 748240, serial# (b)(4), implanted: (b)(6) 2005, product type: extension.Product id: 3387-40, lot# j0519663v, implanted: (b)(6) 2005, product type: lead.Product id: 748240, serial# (b)(4), implanted: (b)(6) 2005, product type: extension.Product id: 7438, serial# (b)(4), implanted: (b)(6) 2005, product type: programmer patient.Product id: 3387-40, lot# j0519663v, implanted: (b)(6) 2005, product type: lead.(b)(4).

• Brand Name: SOLETRA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4654057
• MDR Text Key: 21774104
• Report Number: 3004209178-2015-05882
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• 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: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2007
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2015
• Initial Date FDA Received: 04/02/2015
• Date Device Manufactured: 09/01/2005
• 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: 00041 YR