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 Problems Death (1802); Memory Loss/Impairment (1958); Dysphasia (2195); Cognitive Changes (2551)

Event Date 05/16/2013

Event Type  Death  

Event Description

It was reported the patient died in their sleep overnight.The stimulator was noted to be switched off.The patient was hospitalized prior to death for memory problems.The cause of death was unknown and an autopsy was performed, but no clear cause of death was noted.Tests were still ongoing.It was unknown if the death was device related or not.Additional information reported the patient had been hospitalized to investigate and objectivize complaints of memory problems, continued episodes of absent behavior, word finding problems, and not being able to establish contact with others.Stimulation amplitude was decreased, but the problems persisted and memory problems increased.During the stay the patient was found dead in their bed.Additional information from the physicians reported that a sudden unexpected death based on epilepsy was one possible cause of death.Epilepsy was only suspected and not proven.A second possibility was an arrhythmia with finally ventricular fibrillation or asystole which could explain the absences, the fall beside the bed, and loss of consciousness in the cafeteria.The physician indicated that it was hard to say if the death was caused by the stimulator, but they suspected not.The stimulator was turned off at night and the patient died overnight.The stimulators were noted to be off at the time of death.The absences occurred not only when the stimulator was off.The night before death the patient had noted the stimulator was programmed fine because they felt really good again.The autopsy showed no macroscopic organ abnormalities and no histological abnormalities.Further histological examination was to be d one.Such results did not exclude epilepsy nor arrhythmia as cause of death.There was no clear explanation of death at the time.The differential diagnosis remained as sudden unexpected death with epilepsy or a cardiac arrhythmia.Since the stimulator was switched off at the time of death it was particularly unlikely that the stimulation would have played a role in the death.There was no reason to think that the stimulation lead to epilepsy.Two eeg¿s and 24 hour eec showed no epileptic form of activity.Additionally no major deviations were observed.There was only congestive to hemorrhagic edema seen in the lung biopsies that could not fit asphyxia.It was questionable if it was a result of seizure.Brain dissection would still be executed but provisionally by exclusion it was assumed an epilepsy related death.The physician noted it was there personal opinion that the death was not unrelated to the stimulator.Refer to manufacturer report # 9614453-2012-00006 and 9614453-2012-00007 for information on previous symptoms of absent behavior, word finding problems, and not being able to establish contact.

Manufacturer Narrative

Concomitant medical products: product id: 37601, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator.(b)(4).

• 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: 4527762
• MDR Text Key: 5494915
• Report Number: 9614453-2015-00497
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: Physician
• Type of Report: Initial
• Report Date: 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2014
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2015
• Date Device Manufactured: 12/19/2012
• 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): Death
• Patient Age: 00025 YR
• Patient Weight: 65