MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION KINETRA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 7428

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

Patient Problems Anxiety (2328); Depression (2361)

Event Date 03/15/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the obsessive compulsive disorder (ocd) patient experienced a ¿depressive and anxious episode during hospitalization.¿ it was further reported the patient experienced a ¿severe¿ anxious episode and reportedly required extended hospitalization from (b)(6) 2012 (b)(6) 2012, though the event date was reported as (b)(6) 2012.It was stated the patient's ¿anxiety syndrome increased during the intervention.¿ though the issue was reported as both possibly and ¿probably due to the implant surgery,¿ it was noted the issue occurred ¿several days and several weeks¿ after placement of the patient's device.It was stated the issue was ¿improbably linked to the neurostimulator¿ and that in regards to whether the patient's medical device was possibly related to the serious adverse event it was reported ¿no.¿ the healthcare professional (hcp) involved with the event indicated the serious adverse event seemed to be mostly related to ¿disease progression¿ and an illegible second component.The hcp also declared the issue was an expected serious adverse event and that it was related to the implementation procedure of the medical device.Actions and interventions that were taken as a result of the event were reportedly ¿changes in antidepressant treatment with improvement.¿ there were no other etiologies considered and no additional tests performed.It was noted the issue was resolved at the time of report.It was additionally noted the issue had resolved on (b)(6)2012.No surgical interventions were performed and it was unknown if any were planned at the time of report.Additional information was requested; a supplemental report will be filed if additional information is received.

• Brand Name: KINETRA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• 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: 5508803
• MDR Text Key: 40636339
• Report Number: 3007566237-2016-01417
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2016
• 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
• Patient Age: 00050 YR