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

Model Number 37601

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

Patient Problem Sleep Dysfunction (2517)

Event Date 08/06/2012

Event Type  Injury  

Event Description

It was reported that the patient had insomnia.It was noted that the patient hypnotic medication was readjusted.It was noted that risperidone was substituted for quetiapine.It was also noted that qutiapine, lormetazepam and introduction of clotiapine was stop.The medication adjustment was adjusted to variable dosages of diazepam.There was no diagnostic method.It was noted that the programming/stimulation was probable related.The reported etiology was unclear following the study relationship, relationship to device, and possibly related relationship to procedure.¿unlikely related¿ was noted at the end of information.It was further reported that medication adjustment also included increased dosage of quetiapine to 200 mg on (b)(6) 2013, 400 mg on (b)(6) 2013, and the introduction of trazodone 100 mg/d and mirtazapine 30 mg/d on (b)(6) 2013.The event was marked as ongoing.It was also stated that the patient had suffered from insomnia since the first month after implantation (fluctuating in severity and presentation: sleep onset insomnia, sleep fragmentation).Additional information received reported the patient outcome was resolved without sequelae on (b)(6) 2013.It was noted that the patient had attended to emergency room on (b)(6) 2012 due to persisting insomnia.It was noted that they thought difficulties in stabilizing insomnia were due to an stimulation direct effect of deep brain stimulator.It was further noted that this had resulted in in-patient hospitalization.Patient was admitted to the hospital on (b)(6) 2012 and discharged on (b)(6)2012.

Event Description

Additional information updated the event date from (b)(6) 2012.The intervention was also updated to included increasing quetiapine from 400 to 475 mg per day.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Event date was updated.

Event Description

Additional information reported the mirtazapine was increased from 30 milligram per day to 45 milligram per day.

Event Description

Additional information reported the patient went to the emergency room on (b)(6) 2012.In-patient hospitalization was removed from the event.

• Brand Name: ACTIVA
• 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: 3581652
• MDR Text Key: 4031111
• Report Number: 9614453-2014-00013
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2014
• 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: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2014
• Date Device Manufactured: 05/25/2012
• 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