MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37603

Device Problem Positioning Problem (3009)

Patient Problems Stroke/CVA (1770); Visual Impairment (2138); Visual Disturbances (2140); Weakness (2145); Dysphasia (2195); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that when the patient had woken up in recovery on (b)(6) 2014 after the deep brain stimulator implant they had vision, balance and speech problems on their right side.The patient had nothing but problems with the left implantable neurostimulator (ins).The side that controlled the patient¿s left arm worked well in controlling the tremors, but the side the controlled the right arm was giving him trouble.The patient could not move his eyes which contributed to his movement and instability problems.The patient was also agitated and weak and used a walker.The patient used a walker full time now and they were not doing well.Two years prior to this report the patient was very active and they could not do anything at the time of this report.When the patient¿s right side was turned on the reporter could not understand what the patient was saying.The patient was looking into having the inss removed.The patient had spoken to their healthcare professional (hcp) who thought they could take the ins out and leave the wires and electrodes in place, but they did not want to do that.The patient¿s vision, balance, and speech were affected in the recovery room after implant and the hcp stated they had problems finding a spot that it would not affect.The patient did not have any problems going into surgery.In the recovery room the patient¿s speech was altered and their eyes were fixed at the ceiling so a ct scan was ordered because the hcp thought the patient had a stroke.In (b)(6) the patient went back to their hcp and they tried reprogramming five times, but the patient¿s symptoms got worse.The patient waited for the swelling to go down and the symptoms to resolve, but it¿s now december and the patient still had problems.The reporter thought the wires and electrodes caused the problem and removing them did not guarantee the problem would go away.The reporter stated the hcp told them they had to do more than one tunnel to find the right spot.The reporter further stated they wanted to know why the patient could not have all of the leads taken out.The hcp stated they were willing to remove the ins in about three weeks after this report.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator; product id 3389s-40, lot# va0jlr4, implanted: (b)(6) 2014, product type: lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 3389s-40, lot# va074ht, implanted: (b)(6) 2014, product type: lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 3389s-40, lot# va0jlr4, implanted: (b)(6) 2014, product type: lead; product id 3389s-40, lot# va074ht, implanted: (b)(6) 2014, product type: lead; product id 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.(b)(4).

Event Description

Additional information received reported that the device had not worked for the patient since implant and he had had really bad side effects with it.The surgeon agreed to remove the implantable neurostimulator (ins) and leads ¿in a few weeks.¿ two weeks later it was reported that the entire system was explanted.

Manufacturer Narrative

(b)(4).

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 4326957
• MDR Text Key: 5252020
• Report Number: 3004209178-2014-23891
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2015
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2015
• Date Device Manufactured: 05/16/2014
• 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): Other; Required Intervention
• Patient Age: 00072 YR