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

Model Number 7426

Device Problems Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927)

Patient Problems Cardiopulmonary Arrest (1765); Foreign Body Reaction (1868); Muscular Rigidity (1968); Neurological Deficit/Dysfunction (1982); Pain (1994); Paralysis (1997); Therapeutic Effects, Unexpected (2099); Dysphasia (2195); Distress (2329); Complaint, Ill-Defined (2331); Shaking/Tremors (2515); Ambulation Difficulties (2544); Device Embedded In Tissue or Plaque (3165)

Event Date 01/24/2011

Event Type  Injury  

Event Description

It was reported, the patient experienced ¿spasticity and shaking.¿ it was stated, the patient was unable to say whether they had spasticity and shaking before the implant.It was noted, the patient was to have her device taken out in ¿about a month¿ after report because, the patient felt ¿she should not have had it in the first place.¿ the patient reported her ¿speech was not right¿ and that ¿she was on many other medications that might be affecting her.¿ the patient was redirected to her health care provider (hcp).The patient¿s physician reported the cause of the patient¿s event was ¿unknown.¿ regarding any abnormal impedance measurements, it was reported there were ¿none.¿ it was stated, the patient did not require hospitalization due to the event and had ¿no injury.¿ it was reported that the patient had deep brain stimulation (dbs) to control dystonia contractions.It was noted that the patient and her healthcare professional (hcp) were considering taking the implant and leads out.It was noted that the patient thought that their body was rejecting the device.It was noted that it did not do a good job for varicella.It was noted that the patient had nerve pain going on.It was noted that the patient was not able to answer questions regarding when the problems started and was not able to provide more details about her therapy.It was noted that the patient programmer was missing at the time of the call.It was noted that the patient wanted to make sure her device was off.The patient stated that her husband had committed suicide and she had bad memories and everything was blurred.It was noted that the patient was upset that it was not able to be determined if the device was on or off due to her missing the patient programmer at the time of call.Additional information received reported that the cause of the event was unknown.It was noted that the patient was implanted in (b)(6).It was noted that the patient requested that deep brain stimulation (dbs) be on off state as she no longer used it.It was noted that the patient went in with dbs off and that the doctor confirmed that it was off.It was noted that it was unknown if the patient required hospitalization as a result of the event.It was noted that the patient wanted dbs removed but the patient needed to see her doctor in (b)(6) who performed dbs.It was noted that the patient did not wish dbs to be turned on.It was noted that the patient had not called since.It was later reported that the patient wanted to find out if her therapy was turned off.The patient had been playing with her patient programmer on (b)(6) 2014 and wanted to make sure it was telling her the implantable neurostimulators (ins)s were both turned off.The patient was able to use the patient programmer to communicate with the inss and reported that the 9v battery was low but it was able to check the inss with the patient programmer.The patient described an amber light on and 2 lower green lights on.Amber light meant inss were off.Both sides were checked and they both showed off.It was noted that the patient discussed removing the system but was unable to discuss questions about her therapy.Patient noted that she had had a bad couple of years and had lost time.The patient also stated that ¿implant for her it does not work and she was not sure if she would have the reaction, still probably will but taking the leads out would maybe get rid of the refined pain.¿ the patient also said ¿a long time the healthcare professional accessed it and said, he did the test/said it did not need it.¿ the patient had previously taken xanax and it had taken her 4 days to get off of it.The patient had inderol that she took.It was noted that if her guardian, her father, did not get her prescription for adavan she would check herself into the hospital.It was further noted that when her mother was there she had to rush her to the doctor stating ¿if you are in a reaction you can lose weight like crazy because, the muscles were turning so hard.¿ the patient did not have a schedule, she was bipolar and did not have children because of the illness.It was further noted that the patient had stayed in several hotels in (b)(64) and (b)(6) and at the hotels something on her or inside of her kept turning the keys.It was noted that it was funny because, it had happened at every place and 7 times they had to call the guy to torch the door.

Manufacturer Narrative

Product id 7426, serial# (b)(4), implanted: 2011 (b)(6); product type implantable neurostimulator product id 7438, serial# (b)(4); product type programmer, patient product id 7482a40, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 3387s-40, lot# v550216, implanted: 2011 (b)(6); product type lead product id 7482a40, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 3387s-40, lot# v525542, implanted: 2011 (b)(6); product type lead product id 3387s-40, lot# v550216, implanted: 2011 (b)(6); product type lead product id 7482a40, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 3387s-40, lot# v525542, implanted: 2011 (b)(6); product type lead product id 7482a40, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 7426, serial# (b)(4), implanted: 2011 (b)(6), product type implantable neurostimulator.(b)(4).

Manufacturer Narrative

Concomitant medical products: product id: 7426, serial# (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator.Product id: 7438, serial# (b)(4), product type: programmer, patient.Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2011, product type: extension.Product id: 3387s-40, lot# v550216, implanted: (b)(6) 2011, product type: lead.Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2011, product type: extension.Product id: 3387s-40, lot# v525542, implanted: (b)(6) 2011, product type: lead.Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2011, product type: extension.(b)(4).

Event Description

It was later reported that the patient was going to take her deep brain stimulator implants out.It was stated that patient "cannot fake these symptoms" patient got it from the medicine."the patient's deep brain stimulator was implanted to treat "spasticity and reactions.".It was noted that the deep brain stimulator had not helped those symptoms since implant.It was noted that on (b)(6) 2014 patient was sent home from the healthcare professional's office in a "full blown dystonic reaction" after implant surgery.It was further noted that the patient had "arrested on the table" during the implant surgery.

Manufacturer Narrative

Concomitant medical products: product id 7426, serial# (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator.Product id 7426, serial# (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator.Product id 7482a40, serial# (b)(4), implanted: (b)(6) 2011, product type: extension.Product id 3387s-40, lot# v550216, implanted: (b)(6) 2011, product type: lead.Product id 7482a40, serial# (b)(4), implanted: (b)(6) 2011, product type: extension.Product id 3387s-40, lot# v525542, implanted: (b)(6) 2011, product type: lead.Product id 3387s-40, lot# v550216, implanted: (b)(6) 2011, product type: lead.Product id 7482a40, serial# (b)(4), implanted: (b)(6) 2011, product type: extension.Product id 3387s-40, lot# v525542, implanted: (b)(6) 2011, product type: lead.Product id 7482a40, serial# (b)(4), implanted: (b)(6) 2011, product type: extension.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

Additional information was received from a patient.It was reported that the patient coded on the table when the second implant was placed, but recovered.The patient also reported that the "wires have moved to the left side and went haywire" causing pain and various symptoms; the patient did not know when it began occurring but stated, recently.It was stated that the "various symptoms" included walking with a limp on her left side, knees starting to hurt, and right shoulder pain for the second time (it is unknown when the first time occurred or if it was resolved).The patient noted that the cause of the wires moving was due to her being too small.The patient also stated that she woke up on the day of this report and could not move her left arm.It was confirmed that there was no trauma or falls related to the issue, but the patient did express that she would speak with her health care provider (hcp) about taking the implantable neurostimulator (ins) out.The patient stated she would call back once she buys a 9v battery to check the implant as she wanted to turn it off due to her using an "aleve patch".The patients medical history included allergies to dyes in medication, spinal injections of balclofen, atavan, progentin, and benadryl.

• Brand Name: SOLETRA
• 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: 3820188
• MDR Text Key: 4400195
• Report Number: 3004209178-2014-09247
• 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,consumer,health profess
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2012
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2016
• Date Device Manufactured: 11/08/2010
• 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): Life Threatening; Required Intervention
• Patient Age: 44 YR