MAUDE Adverse Event Report: IPG MFG SWITZERLAND KINETRA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 7428

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

Patient Problems Unspecified Infection (1930); Seizures (2063)

Event Date 01/19/2014

Event Type  Injury  

Event Description

It was reported the patient had an epileptic seizure (b)(6) 2014.It was noted this was a new illness, injury, or condition that was not related to the device or the procedure.It was noted the situation was evolving at the time and that the patient would see the physician in a couple of days.The severity of the event was noted as severe.The event resulted in in-patient hospitalization and prolonged existing hospitalization.It was a life threatening situation that resulted in permanent impairment of a body structure or a body function.It necessitated medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.It was also noted it resulted in fetal distress, fetal death or a congenital abnormality or birth defect.It was noted as no serious adverse device effect.Additional information reported the patient was awake and able to spontaneously move their limbs.It was also confirmed there was no fetal distress, fetal death or a congenital abnormality or birth defect.It was not known at the time if the event resulted in permanent impairment.The leads and stimulator had been explanted and an infection was detected.

Event Description

Additional information reported the intervention included being admitted to the intensive care unit, intubated, treated with antiepileptic medication and antibiotics.Laboratory tests were positive for staph epidermis.Physical examination revealed seizures, hypotension, fever and coma.The surgeon suspected left basal pneumonia and was awaiting results.Additional information reported the extensions were explanted with the leads and stimulator.The system was explanted due to the infection.It was also noted that the epileptic seizure was probably related to the infection.There was no permanent impairment to the patient.The patient is continuously improving, has no fever, is alert, and can move their limbs.The pneumonia for which the patient was intubated was under regression.

Event Description

Additional information received reported that the outcome resolved without sequelae on (b)(6) 2014.It was noted that the patient was admitted to the icu, intubated, treated with sodium valproate 1800mg, haloperidol 2 mg, quetiapine 100 mg, omeprazol 40 mg, calciheparin 8000ui twice a day, clomipramine 25 mg, oxaciliine, ceftriaxo intervention on (b)(6) 2014.Additional information received reported that interventions included medical or non-surgical therapy.It was noted that the patient was admitted to the icu, intubated, and treated with glazidin oxacillinevalproate haloperidolquetiapine, omeprazol calciheparin clo mipramine 25mg on (b)(6) 2014.It was noted that the infection intervention date was (b)(6) 2014.It was noted that the laboratory test resulted in electrocatheter microbiological test was positive for staph epidermidis.It was noted that examination results showed seizures, hypotension, fever, and coma.It was noted that ct scan with contrast showed infection on (b)(6) 2014.It was noted that an mri without contrast showed no signs of infections on (b)(6) 2014.It was noted that the event resulted in in-patient hospitalization.It was noted that the event resulted in prolongation of existing hospitalization.It was noted that it was a life threatening situation.It was noted that the event resulted in permanent impairment of a body structure or a body function.It was noted that the event necessitated medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or body function.It was noted that the patient was admitted to the hospital on (b)(6) 2014 and discharged on (b)(6) 2014.Additional information received reported that the patient suffered a generalized tonic-clonic seizure resulting from an intracranial infection by methicillin resistant staph epidermidis infection.It was noted that there were no signs or symptoms.It was noted that the patient had been discharged from the hospital and had no residual signs of infection.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Concomitant products: product id 3391-40, lot # 0207181047, explanted: (b)(6) 2014, product type lead; product id 3391-40, lot # 0207181046, product type lead; product id neu_unknown_ext, explanted: (b)(6) 2014, product type extension; product id neu_unknown_ext, explanted: (b)(6) 2014, product type extension.(b)(4).

Event Description

Additional information reported the explant occurred on (b)(6) 2014.

Manufacturer Narrative

(b)(4).

Event Description

Additional information reported the adverse events were resolved without sequelae except for the bronchopneumonia.The bronchopneumonia was resolved with sequelae with evidence of modest disventilation at the chest x-ray.

Event Description

Additional information reported the patient had an intracranial infection that was treated with antibiotics.Ct scan confirmed intra cranial infection.It was also noted the patient had a sinus infection.A week and a half later a mri showed no residual signs of infection.The patient also had left basal pneumonia that was hospital acquired while hospitalized for seizures.Bronchoaspiration microbiological testing was positive for pseudomonas aeruginosa.Ct scan showed small left pleural effusion.The seizures lasted approximately one day and it was not known how many seizures occurred.The patient was given antibiotics for the pneumonia.The patient was in medical shock and needed to be re-animated.The patient was given a noradrenaline intervention.The patient also was in a pharmacologically induced coma.Glasgow coma scale results showed gcs 4 sedation and intubation was needed.All events were unlikely related to the device or therapy and not related to the implant procedure.Eeg results showed diffuse delta activity mainly in the frontal regions particularly on the right hemisphere.The events were considered resolved with sequelae.X-ray showed evidence of slight dis-ventilation of left pulmonary base, slight thickening of the pleural wall.There was no evidence of pneumothorax.The patient has been discharged from the hospital and has no residual signs of infection.The patient had no history of seizure.The seizures were noted as likely caused by the brain infection.It was unlikely the infection was related to the implant surgery which took place five months prior to the infection.

Manufacturer Narrative

(b)(4).

• Brand Name: KINETRA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• 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: 3630279
• MDR Text Key: 3990906
• Report Number: 9614453-2014-00417
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2013
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2014
• Date Device Manufactured: 05/14/2012
• 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): Hospitalization; Life Threatening; Required Intervention