MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION

Model Number NEU_INS_STIMULATOR

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 04/14/2017

Event Type  Injury  

Manufacturer Narrative

Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.The device was used for an off label indication.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Lim, lh., noma fitzrol, d., rajapathy, sk., tan, yc., sanihah, ah., kandasamy, r., wan hassan, wmn., badrisyah, i., abdul rahman izaini, g., zamzuri, i., tharakan, j., nunta-aree, s., jafri malin, a.Deep brain stimulation (dbs) for movement disorders: an experience in hospital universiti sains malaysia (husm) involving 12 patients.Malaysian journal of medical sciences.2017;24(2):87-93.Doi: 10.21315/mjms2017.24.2.11.Summary: deep brain stimulation (dbs) was first introduced in 1987 to the developed world.As a developing country malaysia begun its movement disorder program by doing ablation therapy using the radionics system.Hospital universiti sains malaysia a rural based teaching hospital had to take into consideration both health economics and outcomes in the area that it was providing neurosurgical care for when it initiated its deep brain stimulation program.Most of the patients were from the low to medium social economic groups and could not afford payment for a dbs implant.We concentrated our dbs services to parkinson's disease, tourette's syndrome and dystonia patients who had exhausted medical therapy.The case series of these patients and their follow-up are presented in this brief communication.Reported events: 1.Case 12: a (b)(6) male with deep brain stimulation (dbs) of the medial thalamus for tourette¿s syndrome experienced an allergic reaction to the device shortly after implant so the device was removed.It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6624659
• MDR Text Key: 77231677
• Report Number: 3007566237-2017-02268
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2017
• 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): Required Intervention
• Patient Age: 22 YR