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

Model Number 37612

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Loss of Range of Motion (2032); Urinary Tract Infection (2120); Dysphasia (2195); Ambulation Difficulties (2544)

Event Date 11/24/2014

Event Type  Injury  

Event Description

It was reported that there was a left brain stroke at implant.The patient was unable to speak and had limited movement of the right arm and leg.The patient had been doing in-patient rehab from (b)(6) 2014.The patient had gone home for (b)(6) and had been doing day rehab since then monday through friday 9am to 3pm.The patient¿s father inquired if the patient could have ¿e-stim.¿ the rehab used it to stimulate the muscles in the patient¿s right arm and leg to try and regain some movement and ability.The patient¿s deep brain stimulator was implanted near the left collarbone.They did not think the stimulation was used on the patient¿s right shoulder.The deep brain stimulator had been turned on within the last two weeks prior to the date of this report.It was unknown if the stroke was related to the surgery, at the time they had not been sure that it was a stroke or if it had possibly been some swelling that came with that type of a procedure.The procedure was done on a monday and on tuesday or w ednesday of the same week they had done an mri to see what was happening and at that time there was nothing definitive.It was noted that the way the leads were implanted were possibly obstructing the view.The father¿s impression was that they could not really tell what had happened because they could not see.In 2014 prior to implant the patient¿s disease had started to change and due to the changes within that last year they had decided to go ahead and try the implant.The patient was on a ton of medication and was now almost of all of the medications.The patient was moving better than she had in a long time.When the patient had come out of the procedure she was unable to speak or move her right side.The patient was now able to speak, her voice was a lot fainter than before but was able to speak.The patient really did not use the wheelchair at all now, she walked kind of slow and was unable to walk distances.It was noted that prior to the implant the patient was in a wheelchair.They were in the process of slowly adjust ing the deep brain stimulator at the time of this report.The patient¿s father was concerned because he was informed to not allow the therapist to use any therapeutic ultrasound on the patient and he had remembered the patient had diagnostic ultrasounds when she was in the hospital recovering from the stroke.The patient had a urinary tract infection (uti) in december prior to the date of this report while in the hospital.Because of the catheter they were monitoring the patient¿s bladder and doing ultrasounds pretty much every time she eliminated they wanted to scan her bladder.No outcome was provided.Further follow-up is being conducted to obtain this information.If additional information is received a supplemental report will be submitted.

Manufacturer Narrative

Concomitant medical products: product id 3389s-40, lot# va0nz7t, implanted: (b)(6) 2014, product type: lead; product id 3389s-40, lot# va0nesh, implanted: (b)(6) 2014, product type: lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.(b)(4).(b)(6).

• 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: 4643960
• MDR Text Key: 5752824
• Report Number: 3004209178-2015-05672
• 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: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2015
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2015
• Date Device Manufactured: 08/27/2014
• 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
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 00010 YR