MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37601

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Complaint, Ill-Defined (2331); Ambulation Difficulties (2544); Electric Shock (2554)

Event Type  malfunction  

Event Description

It was reported that in the two months prior to the report, the patient experienced ¿very strong¿ shocking stimulation sensations in her head with a ¿feeling that she would fall down¿ or not being able to walk.Due to the high energy demands of the patient¿s battery which was close to depletion, a normal replacement was performed.Following the replacement, the patient had better speech and felt ¿much better stimulation than ever¿.[omitted information pertains to unrelated events in pe (b)(4) ¿ wrong position of electrodes and pe (b)(4) ¿ extension insertion difficulty].

Manufacturer Narrative

Product id: neu_unknown_lead, lot# unknown, implanted: (b)(6) 2013, product type: lead.Product id: neu_unknown_lead, lot# unknown, implanted: (b)(6) 2013, product type: lead.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2015, product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: extension.(b)(4).

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• 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: 4706495
• MDR Text Key: 5723626
• Report Number: 3007566237-2015-01044
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2015

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 Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2015
• Initial Date FDA Received: 04/20/2015
• 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: 00047 YR
• Patient Weight: 58