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

Model Number 7428

Device Problems Low Battery (2584); Device Operates Differently Than Expected (2913)

Patient Problems Memory Loss/Impairment (1958); Seizures (2063); Distress (2329)

Event Type  Injury  

Event Description

It was initially reported that the patient had recently been having some seizures.The patient stated that the patient was a ¿study patient or lab rat if you will,¿ for epilepsy.The patient used to have 5 seizures per day and many grand mal seizures.It was reported that the patient¿s neurologist wanted to remove her implantable neurostimulator (ins), since it did not pass the ¿(b)(4) approval¿.It was noted that the patient needed to have a ¿recharge,¿ but the ins listed for the patient was not a rechargeable type.The patient was told they could have ¿two more charges and that was it.¿ it was unclear what the patient meant by this.The patient had concerns about what was to happen to their therapy when the battery ran out.It was also noted that the patient ¿donated her memory and half of her right temporal lobe.¿ the patient also request information on why the deep brain stimulator works so well for their seizures.It was later reported on the same date that the patient had memory loss.The patient stated that half of their right temporal lobe had been removed.The patient stated that during the ¿recharge¿ procedure, lead wires were put to their head and then plugged into the wall.It was noted that this procedure would not recharge the patient¿s implant, as their device was not rechargeable.Additional information received on (b)(6) 2013 reported that the patient had been having a few ¿b and c¿ seizures as of the last six months.The most recent seizure was a ¿c¿ seizure on the ¿(b)(6).¿ it was unclear which month the patient was referring to.It was noted that the seizures were not as severe as the grand mal seizures they had previous to the deep brain stimulation (dbs) implant.The patient stated that the device had helped them ¿greatly¿ with their epilepsy.Further information received on the same day reported that the patient had ¿about five b or c¿ seizures in the past month.The patient thought that the implantable neurostimulator (ins) battery needed to be replaced because, they had the implant for a long time.The patient indicated that the device was helping with their epilepsy and they wanted the trial to continue.Additional information received on (b)(6) 2013 confirmed that the reported the ins device worked very well for the patient¿s seizures.The patient stated that their healthcare professional (hcp) wanted to take the device out but the patient did not want to have it taken out.Further information received on (b)(6) 2013 reported the patient¿s neurologist wanted to have the ins device removed because, ¿it¿s not working.¿ the patient thought the ins was working, but the battery was dead but was unsure when it went dead.The patient¿s trial was over and the patient had been having more seizures which was noted as starting up again ¿years ago¿.It was reported that the patient never heard a ¿beep¿ which told them the ins was dead.The patient was told the study they were in had been shut down in was reported as not shut down but was clarified that is was not.Based on evaluations of the patient¿s seizure history over the course of the study (began in (b)(6) 2004), it was reported that their seizures have not improved with stimulation, even before her battery reached end-of-life (eol) and was the reason the hcp recommended explant for her.The hcp felt it was not ethical to continue having her undergo surgical battery replacements if she is not benefitting from the therapy.Additional information received on (b)(6) 2013 reported that the patient was diagnosed with epilepsy and had an increase in seizures since moving and thought the increase in seizures was related to stress.It was noted that the patient¿s current doctor wanted to remove the ins device.The patient did not want to have the dbs therapy removed as they thought it was helping them.It was reported, however, that their doctor was ¿not supporting of that¿.Further information received on (b)(6) 2013 reported that the patient wanted a replacement of the ins device as they felt it was effective in treating their seizures.However, the patient¿s hcp did not want to implant a new one.It was noted that when the patient had a seizure, she had a movement beyond her control, so epilepsy was a ¿movement.¿ if additional information is received, a follow up report will be sent.

Event Description

It was reported the patient¿s former physician wanted them to take out the stimulator and that they would not see the patient until the stimulator was removed.The stimulator was dead and needed to be replaced.It was noted they thought it had reached its normal battery depletion.The patient thought the device worked really well.The patient had kept a diary and noticed they were going days without seizures.It was also noted the former neurologists did not notice improvement with the seizures and therapy.A couple of days ago the patient had a hard ¿c¿ seizure.Additional information from the study noted the physician did not feel the stimulator should be replaced, instead that the subject should be discontinued from the study.The patient had been referred to another physician to see if they would authorize stimulator replacement.

Event Description

Additional information received reported the patient was a ¿study patient¿ 12 year ago for deep brain stimulation (dbs) therapy for treatment of grand mal seizures and it was mentioned the therapy worked for her.The patient¿s seizures started again 2 months ago.The patient¿s neurologist would not work with her until she had the deep brain stimulation (dbs) therapy removed, but the patient did not want the device removed, she wanted the implantable neurostimulator (ins) battery replaced.The ins battery depletion was normal and it was mentioned the ins battery had been dead for a long time (¿years¿).The patient was receiving collection calls from ou medical center about the dbs surgery.The patient was going to have the therapy removed now because it had not been fda approved.A neurologist in oklahoma city told the patient there was no improvement with the dbs therapy, but the patient disagreed.The doctor told the patient she would not follow her again until dbs therapy was removed.The patient had not had a grandma seizure since implant of dbs.The patient wanted her battery replaced, but her doctor would not replace it.

Manufacturer Narrative

Product id 7482a51, serial# (b)(4), implanted: 2007 (b)(6); product type extension product id 3387-40, lot# j0427795v, implanted: 2004 (b)(6); product type lead product id 3387-40, lot# j0427795v, implanted: 2004 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 7436, serial# (b)(4), implanted: 2004 (b)(6); product type programmer, patient.(b)(4).This device was being used in an clinical trial for the treatment of adult refractory epilepsy.

Manufacturer Narrative

(b)(4).

Event Description

Additional information reported no action had been taken and the event was considered resolved without sequelae.

Event Description

Additional information reported the patient had a lack of efficacy.The battery was at end of life but no replacement was to occur.The event was considered resolved without sequelae.

Manufacturer Narrative

(b)(4).

Event Description

Additional information reported the patient had a loss of therapeutic effect.The loss of effect began a few months prior and came on suddenly.It was noted the patient's stimulator was "unplugged".The patient needed a new battery due to hers being depleted.The battery was believed to have been deleted for a few years and the patient had been experiencing more frequent and more severe seizures.

• Brand Name: KINETRA
• 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: 3645126
• MDR Text Key: 4181593
• Report Number: 3004209178-2014-03540
• 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: Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/20/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2010
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2014
• Date Device Manufactured: 06/16/2009
• 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