MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN DEEP BRAIN NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number NEU_INS_STIMULATOR

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

Patient Problems Erythema (1840); Unspecified Infection (1930); Pain (1994); Swelling (2091); Test Result (2695)

Event Date 11/13/2016

Event Type  Injury  

Manufacturer Narrative

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

A healthcare professional (hcp) for a clinical study reported via a representative that there was a diagnosis of device infection which required hospitalization.The patient presented and was admitted to the hospital on (b)(6) 2016 for increased swelling and pain surrounding implanted right chest battery device following surgery insertion on (b)(6) 2016.Blood tests showed raised crf (corticotrophin-releasing hormone) of 105 and normal white cell count; intravenous (iv) flucloxacillin was commenced on (b)(6) 2016.The patient was transferred and admitted to another hospital on (b)(6) 2016 and was assessed by hcps for further treatment and infection control advice, including blood tests and iv antibiotics.Device site infection was diagnosed on (b)(6) 2016 with some mild erythema and swelling around the battery site.On (b)(6) 2016, the patient was discharged.Follow-up appointments with the hcps occurred on (b)(6) 2016.The iv antibiotics, which were administered from (b)(6) 2016 until discharge, settled the erythema and swelling.The patient remained on oral antibiotics since discharge and had a follow-up appointment scheduled for (b)(6) 2016.The outcome was described as ¿continuing¿ but the event did not require device removal.Relationship to device was ¿probable.¿.

• Brand Name: UNKNOWN DEEP BRAIN NEUROSTIMULATOR
• 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; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6198907
• MDR Text Key: 63108926
• Report Number: 3007566237-2016-04516
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2016
• 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; Required Intervention