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

Model Number 3387-40

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Erosion (1750); Fungal Infection (2419)

Event Date 07/05/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported there was erosion of the wound over the right burr cap and lead.The hardware was visible.It was reported there were no obvious signs of infection.No external/environmental/patient factors were thought to have led or contributed to the issue.The wound was surgically washed out and closed.The issue was resolved and the patient was alive without injury at the time of the report.No further complications were reported or anticipated.

Manufacturer Narrative

No further information received for this event will be reported in this regulatory report.All additional information will be submitted in regulatory report #3004209178-2018-21150.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare provider via the manufacturer representative (rep) indicating that there was again erosion and signs of infection at the scalp incisions.No environmental/external/patient factors were thought to have led or contributed to the issue.Yeast and pseudomonas was confirmed on (b)(6) 2018.Interventions/actions included all products explanted on (b)(6) 2018.The issue is reported to be resolved at the time of this report.All devices were discarded and will not be returned for analysis.No further complications were reported or anticipated with this event.

Manufacturer Narrative

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

• Brand Name: ACTIVA
• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7670666
• MDR Text Key: 113458869
• Report Number: 3007566237-2018-02025
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3387-40
• Device Catalogue Number: 3387-40
• Device Lot Number: V008172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• 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: 64 YR
• Patient Weight: 77