MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37602

Device Problems Electromagnetic Interference (1194); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem Muscle Spasm(s) (1966)

Event Type  malfunction  

Event Description

It was reported the patient had been having muscle spasms since going through the theft detector gate at the (b)(6) a couple of weeks ago.Her settings were at 2.99 v and the representative told her she was supposed to be set at left "side 3.5 ((b)(4))" and had no right side on her programmer.The patient only had one setting.It was noted the patient did not know how to adjust it and was told by her physician to give it 1-2 days and it would re-stimulate.After 1-2 days, the patient was getting back to normal but wasn't at normal yet.The patient would have spasms when going out in the cold as well.The patient tried to check her device with her programmer but was seeing mdt 2.1 and another screen that would not tell her if she was on and okay.An information screen was seen, which indicated the patient's (b)(4) batteries were getting low in the patient programmer.She hit the navigator key to clear the low (b)(4) battery message and the splash screen went back to mdt 2.1.The patient was to get new (b)(4) batteries and see if the issue would resolve.No interventions or outcome was provided regarding this event, so additional information was requested.If additional information is received a supplemental report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 7482a51, serial# (b)(4), implanted: 2007-(b)(6), product type: extension.Product id: 3387s-40, lot# v041389, implanted: 2007-(b)(6), product type: lead.(b)(4).

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; 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: 4569171
• MDR Text Key: 5548846
• Report Number: 3004209178-2015-04086
• 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: Patient
• Type of Report: Initial
• Report Date: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2016
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2015
• Date Device Manufactured: 08/21/2014
• 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