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

Model Number 37601

Device Problems Therapy Delivered to Incorrect Body Area (1508); Unexpected Therapeutic Results (1631); Device Operates Differently Than Expected (2913)

Patient Problems Muscular Rigidity (1968); Neurological Deficit/Dysfunction (1982); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Tingling (2171); Dysphasia (2195); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Malaise (2359); Neck Pain (2433)

Event Date 05/20/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3387s-40, lot# v865879, implanted: (b)(6) 2012, product type: lead.Product id: 3387s-40, lot# v865879, implanted: (b)(6) 2012, product type: lead.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.Product id: 37642, serial# (b)(4), product type: programmer, patient.(b)(4).

Event Description

A consumer reported that the patient was 80% worse since his second implant and that they had no effect.The patient's therapy was 60-70% better with their previous implantable neurostimulator (ins).It had been 3 weeks since his second ins was implanted and it wasn't helping.The patient thought they were "doing good," but within a week of the replacement they were "going downhill" and "they felt like the nightmare was starting over." the patient noticed a slight tingle down their right arm, but it went away with adjustments.The patient also noticed pain felt at middle of spine, numbness, severe burning and that their muscles felt tight within a week after surgery.The patient was "slunched over" like the device was off.The night prior to this report, the patient switched programs back to group a, but all that did was put the pain back where it was and did not improve it.The ins checked to make sure it was on because the patient's head was hurting so bad.The pain in the head was on the back of the skull and ran down the shoulders/neck and happened when the patient lied down.The patient's speech was slurred, their chin bone was one inch from their chest bone and they couldn't lift their head.The patient had turned into a "grouch" because they were hurting again.The patient had tingling in his legs and feet.All of these symptoms started a couple days after implant.A 006 error code was seen on the patient programmer on (b)(6) 2015.The 006 error code went back to the normal screen when the programmer was shut off and turned on again.The patient had woken up with migraines and got sick.The patient could not feel his feet but could move them.The patient later reported that their left arm drew up like they had cerebral palsy after they turned the ins off on (b)(6) 2015.At an eye appointment, "something about the muscles in the patient's eyes" was mentioned.The patient's health care provider (hcp) reported that the cause of the event was determined and was not device related.The loss of efficacy was unrelated to the therapy and reprogramming was reviewed to address stimulation needs.A previously scheduled dbs follow up visit included reprogramming on (b)(6) 2015 and the patient was given groups to use.The patient recovered without permanent impairment and returned to their current baseline.The patient's neck dystonia improved on exam.There were no clear correlations between the patient's symptoms and dbs hardware or programming.The patient later reported the device had not been working properly since may and the patient's movements and functions were diminishing.The device was not working as good as the patient's prior device.The device was not acting the same as the previous one and the patient wished they never had it done.Prior to having the device replaced, the patient was taking very little pain medication, they were standing up straight, and starting to enjoy life.Since a week after the replacement, the patient noticed a return in pain.The patient's upper muscles and legs were affected, they were in a lot of pain, and they would soon be wheel chair bound.The patient had a loss of stimulation.The patient had been to see their health care provider (hcp) about all of the issues, but the hcp would not turn the device up higher.The patient was on program b at 5.4v and the hcp stated that everything seemed good when they connected to the device using the "black box." an appointment with the patient's hcp was scheduled for thursday.The patient's indication for use is dystonia and movement disorders.

Event Description

Additional information received from a health care provider (hcp) reported the patient had significant medical comorbidities and they just completed cervical neck surgery.The implantable neurostimulator (ins) was operating within normal limits and all impedances were measured within normal limits as of (b)(6) 2016.

• 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: 5391084
• MDR Text Key: 37026356
• Report Number: 3004209178-2016-01035
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2016
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2016
• Date Device Manufactured: 11/20/2014
• 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 Age: 00050 YR