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

Model Number 37601

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

Patient Problems Emotional Changes (1831); Fall (1848); Muscle Weakness (1967); Therapeutic Effects, Unexpected (2099); Distress (2329); Complaint, Ill-Defined (2331); Neck Pain (2433); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Cognitive Changes (2551)

Event Type  Injury  

Event Description

It was reported that the last few weeks had been terrible for the patient.She fell several times and had to go to the emergency room (er) to determine if her kneecap was fractured.Her mental state was deteriorating rapidly, as she cried for the better part of a day because of frustration in not being able to walk ten feet without falling down.Her leg strength was completely gone and simply would not support her body.The patient also had significant pain in her neck that never seemed to diminish.Her right side was not functional and she had developed restless leg, which would not allow her to sleep for any length of time.She could barely perform the basic functions to care for herself.Her emotions were running sky high and the reporter¿s fear was that she was in so much agony that she may harm herself in a fit of anger.The patient had minimal trouble walking before implant, but could hardly walk at the time of the report.She was at the two month mark post-surgery and had seen little improvement in her condition.Her overall condition was significantly worse at the time of the report than prior to implant.The only caution presented prior to surgery was that her iq might drop a few points.The reporter felt this was an understatement as the patient was actually acting ¿like an eight year old.¿ the reporter questioned her overall competency.Adjustments to the device had yielded little improvement.The patient could not go on like this much longer as her health was deteriorating rapidly.Follow-up from the manufacturer representative (rep) reported that there was 50% or greater symptom reduction.The patient had three programming sessions and had a follow-up appointment scheduled with her doctor for (b)(6) 2015.It was unknown how the patient was doing, but the therapy was being delivered.The patient had not had her appointment with her doctor yet, so additional information will be requested at a later date.If additional information is received a supplemental report will be sent.

Manufacturer Narrative

Concomitant product/(s): product id: 3708640, serial# (b)(4), implanted: (b)(6) 2015, product type: extension.Product id: 37642,serial# (b)(4), product type: programmer, patient.Product id: 3708640, serial# (b)(4), implanted: (b)(6) 2015, product type: extension.Product id: 3387s-40, lot# va0q888, implanted: (b)(6) 2015, product type: lead.Product id: 3387s-40, lot# va0q888, implanted: (b)(6) 2015, product type: lead.(b)(4).

Event Description

Additional information received reported the patient had made little progress since their last report.The patient had an appointment scheduled with their healthcare professional (hcp) on (b)(6) 2015.The reporter hoped a ct scan would shed some light on why the patient continued to have problems.A ct scan found that in the interval there were findings of deep brain stimulation postoperative changes with bilateral frontal burr holes.The leads were in good anatomic position.There were right frontal subcutaneous postoperative changes with the leads.There appeared to be patch ill define contrast enhancements involving the right posterior frontal cortex and subcortical white matter adjacent to the metallic artifact form the leads.The possibility of an infections or neoplastic process could not be excluded with the examination.The patient's third and fourth lateral ventricles remain mildly increased in size with a proportionate increase in size of the cortical sulci and subarachnoid spaces of the posterior fossa indicative of diffuse mild cerebral and cerebellar atrophy.The multiple areas of mildly decreased density involving the periventricular and subcortical white matter was consistent with white mater changes of aging and microvascular disease.

• 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: 4841044
• MDR Text Key: 17224291
• Report Number: 3004209178-2015-11545
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• 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: 05/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2016
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2015
• Date Device Manufactured: 02/27/2015
• 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 Outcome(s): Other