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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC ACTIVA DYSTONIA THERAPY; DEEP BRAIN STIMULATOR (DBS)
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MEDTRONIC ACTIVA DYSTONIA THERAPY; DEEP BRAIN STIMULATOR (DBS) Back to Search Results
Model Number ACTIVA RC 37612
Device Problem Insufficient Information (3190)
Patient Problems Cardiac Arrest (1762); Death (1802); Hyperventilation (1910); Respiratory Failure (2484)
Event Date 10/30/2016
Event Type  Death  
Event Description
Death at home.Pt with dbs implanted.Per mom, pt was sick, having trouble keeping oxygen saturation above 92%.Pt started to hyperventilate and ems was called.When ems arrived, pt stopped breathing and went into cardiac arrest.We were unable to revive him.Per mom, "he went quickly, without pain." dbs leads were placed on (b)(6) 2015, medtronic 3387s 40 cm electrodes, lot # va0kqxq.Rc ipg was placed on (b)(6) 2015, activa rc 37612 pulse generator, sn # (b)(4).On (b)(6) 2015, two add'l electrodes were placed in bilateral vim nucleus.Per pi, pt died of respiratory failure due to underlying disease.Per pi, this at home death is unrelated to the dbs implant.It is however, related to his underlying disease.No further info is available.
 
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Brand Name
ACTIVA DYSTONIA THERAPY
Type of Device
DEEP BRAIN STIMULATOR (DBS)
Manufacturer (Section D)
MEDTRONIC
minneapolis MN
MDR Report Key6158961
MDR Text Key61908214
Report Number6158961
Device Sequence Number1
Product Code MRU
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2016
Is this an Adverse Event Report? Yes
Device Operator Lay User/Patient
Device Model NumberACTIVA RC 37612
Device Lot NumberVA0KQXQ
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/07/2016
Distributor Facility Aware Date11/30/2016
Event Location Home
Date Report to Manufacturer12/07/2016
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
CLONIDINE; DEPAKENE; NEXIUM; PHENOBARBITAL; SINGULAIR; ZANTAC
Patient Outcome(s) Death;
Patient Age17 YR
Patient Weight40
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