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

Model Number 37612

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Unexpected Therapeutic Results (1631); Vibration (1674); Device Operates Differently Than Expected (2913)

Patient Problems Muscular Rigidity (1968); Pain (1994); Paralysis (1997); Therapeutic Effects, Unexpected (2099); Dysphasia (2195); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Injury (2348); Ambulation Difficulties (2544)

Event Date 03/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device used for off label indication.The indication the device was used for was parkinson's symptoms, freezing of gait, postural instability, and severe bradykinesia.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A patient via the manufacturer representative (rep) reported that the patient is using cortical stimulation to control advanced parkinson's symptoms, freezing of gait, postural instability, and severe bradykinesia.The patient received consistent therapeutic outcome with their first implant, but began to experience severe fluctuations of their condition after battery replacement.It was stated that impedances were checked, and an x-ray was performed to ensure the leads didn't migrate.There are no electric sensations felt by the patient around the system, and from the available date the system is preserved.The patient believes the issue to be product related, and has been looking to characterize the battery output.They used a magnetic field transducer with a voltage output coupled to a voltmeter to access the system, and from their evaluation every time the values drop under a certain defined threshold they get a symptom worsening.The rep doubts system instability but plans to investigate further.The patient's indication for implant is unknown.

Manufacturer Narrative

The mfg site id was updated to (b)(4).

Event Description

Additional information received from a consumer via a manufacturer representative reported that the patient had a feeling of the implantable neurostimulator (ins) vibrating, which they felt no matter how many times the ins "stop for working".The patient felt the vibrating when the ins was on.When the ins stopped and the vibrations lowered, the patient's symptoms of their disease returned.The patient had symptoms of paralysis, difficulty walking/change in gait (fog), difficulty speaking, less than 50 percent therapy relief, and muscle stiffness.The deep brain stimulation was verified using the clinician and patient programmers to determine if a defect had occurred to stop the ins from functioning.At various times during the patient's technical appointment, the patient felt the ins stop vibrating and they had a return of symptoms.When the ins stopped vibrating, the clinician and patient programmers showed the ins was on and okay.The patient was also concerned the ins had lasted a long time when high parameters were used to program therapy.The patient was dependent upon their wife since they could no longer perform tasks by themselves.Interrogation of the ins showed the patient was able to successfully recharge the ins and impedances were within normal range.The ins was programmed to c+, 0-, 1-, 2-, and 3- at 3.2v, 420 usec, and 60 hz on group a.Group a was the primary group used by the patient.No interventions or actions were taken and the issue was not resolved.The patient was alive with temporary injury.The temporary injury was the return of freezing when the patient felt the ins was working intermittently.The manufacturer representative later reported the patient felt the sensation after the ins was replaced.The cause of the event was unknown and no additional diagnostics or troubleshooting was done.No additional actions or interventions had been taken.The patient was receiving therapy, but it was not continuous and in some situations the patient felt as if the device was interrupting the delivery of therapy.

Event Description

Additional information received from a consumer via a manufacturer representative reported the patient had parkinson¿s disease for over nine years.According to the patient¿s health care provider (hcp) they had thalamic pain and sclerosis in addition to their parkinson¿s disease symptoms of freezing of gait.The patient¿s lead was implanted in their motor cortex.The patient was first implanted in 2015 and their quality of life was changed.Prior to implant the patient had extreme difficulties with moving and after implant they were playing basketball.In (b)(6) 2016, the patient¿s implantable neurostimulator (ins) battery wore out and was replaced with a rechargeable ins, which is when the problems started.After being discharged from the hospital, the deep brain stimulation (dbs) presented problems that completely paralyzed the patient and they were sent to the hospital by ambulance.During that year, the patient suffered from the device¿s instability.When the patient felt the device vibrating in their chest they were fine and walking normally, but when the device issued less power the patient became completely paralyzed and they were in great pain.The patient had to turn the ins off and on to try to get the power back to normal, but that did not always happen.The patient¿s prior ins was analyzed and there was no problem, but the patient thought the power over time was not analyzed and it did not show the power fluctuated.The patient stated they were in need of immediate intervention because they were suffering a lot, became paralyzed during several times of the day, and went into the off state when the device reduced the power.The patient suffered from an awful life quality (vegetating) when the device failed and they depended on their wife for everything.On (b)(6) 2017, the patient met with a manufacturing representative.During the meeting, no failure in the delivery of therapy was detected on the clinician or patient programmers despite the patient reporting a ¿feeling of failure and intermittence.¿ the patient had reported two instances of feeling of failure and intermittence during the meeting, but nothing abnormal was found.After the meeting, the patient¿s ins started working again normally with an amplitude of 3v and they had great condition for their quality of life.On (b)(6) 2017, the ins started failing and the patient was in pain and immobilized almost all day.The patient wanted to know why they were in so much pain.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 MN 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6120485
• MDR Text Key: 60653482
• Report Number: 2182208-2016-02603
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2016
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2017
• Date Device Manufactured: 05/01/2015
• 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