MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37602

Device Problems Therapy Delivered to Incorrect Body Area (1508); Device Displays Incorrect Message (2591)

Patient Problems Fall (1848); Undesired Nerve Stimulation (1980); Neurological Deficit/Dysfunction (1982); Therapeutic Effects, Unexpected (2099); Concussion (2192); Dizziness (2194); Dysphasia (2195); Complaint, Ill-Defined (2331); Hip Fracture (2349); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that the device had worked wonderful for the patient¿s upper extremities, but they had dystonia in their left foot that caused their foot to be at almost a 90 degree angle.It had helped with all other symptoms besides the patient¿s foot.This made it impossible for the patient to walk and they kept falling.The patient had this problem before implant.The patient¿s healthcare provider (hcp) instructed them to turn the device off.The hcp thought they could help fix the issues, but wanted the patient to turn stimulation off for a week to week and a half, so they could start over.The patient later reported that he turned stimulation off, but program c was still on.About a month later the patient still had concerns regarding his device or therapy, but was working with their hcp or a manufacturer representative.The patient had an appointment on (b)(6) 2014.The patient knew what a, b, and c were, but wanted to know what they control.The patient wrote that a felt like it was in their legs, b in their voice and they were stuttering, and they did not know what c did.The patient stated they used all three.Six months later the patient reported the patient programmer screen showed the ¿check the implantable neurostimulator (ins)¿ screen.There was a problem with the programmer and the programmer worked intermittently.When the patient checked the ins they got the stimulation turned off screen.The patient tried to turn stimulation back on, but they could not make a connection.The patient saw stimulation off and a flashing triangle with the battery on the top row of the programmer and 3.108 below that.Usually the patient could feel a small voltage going through their body when they move to program b or c, but they did not feel anything at the time of this report.The patient¿s wife stated that it had been worrying the patient a good bit because they had to use the ins more than ever.The patient had symptoms of slurred speech.The patient had turned the ins off for a short period of time and they have never had any trouble with it so they assumed it was the batteries.The reporter stated the patient was beginning to get it a little on the right side.The patient had dystonia real bad and ¿afib¿ that caused them to fall almost every day.When the patient¿s hcp ¿hooked up the final wires¿ the patient was walking again, but their left foot was turning in.The reporter stated the hcp told them that normally the patients get better and they had never seen one get so bad.The patient¿s right foot turned towards the middle and they had a brace on it.The patient did use a walker to walk.The patient¿s foot started turning in about three weeks after surgery.For the past six months the patient was starting to get dizzy when they stood up and tried to take a step.The patient had fallen once close to thanksgiving and then again about six weeks prior to this report.After the first fall the patient had a concussion and after the second fall the patient was taken by ambulance to the hospital because they thought their hip may be broken.The patient had been to the orthopedic hcp twice since then.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 37642, serial# (b)(4), product type: programmer, patient; product id 3 387s-40, lot# va09grv, implanted: (b)(6) 2013, product type: lead; product id 748351, serial# (b)(4), implanted: (b)(6) 2013, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient.(b)(4).

Event Description

Additional information received reported the patient received assistance from a manufacturing representative and their concerns were resolved.Upon device return, analysis of the patient programmer found the complaint was unconfirmed and the antenna jack was resoldered as a preventative measure.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 4386252
• MDR Text Key: 5303688
• Report Number: 3004209178-2015-00173
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2014
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2015
• Date Device Manufactured: 06/25/2013
• 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