MAUDE Adverse Event Report: IPG MFG SWITZERLAND ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37601

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

Patient Problems Inflammation (1932); Injury (2348)

Event Date 10/30/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 3389-40, lot# 0209520777, implanted: (b)(6) 2015, product type: lead.Product id: 3389-40, lot# 0209586814, implanted: (b)(6) 2015, product type: lead.Product id: 3708695, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: extension.Product id: 3708695, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: extension.(b)(4).

Event Description

A healthcare professional from a clinical study reported that post-operatively at an examination on (b)(6) 2015 there was an inflammatory wound about the neurostimulator.Actions taken were in-patient hospitalization and system modification on (b)(6) 2015.The device and extension were explanted and replaced on (b)(6) 2015.The patient was alive with injury.The patient was recovered without sequelae.This was not related to the component and not related to programming/stimulation.It was procedure related.Patient's medical history included breast cancer and dystonia; the patient was taking movement disorder or psychiatric medications.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• 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: 5246183
• MDR Text Key: 32015207
• Report Number: 9614453-2015-02714
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2016
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2015
• Date Device Manufactured: 04/28/2015
• 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
• Patient Age: 00059 YR
• Patient Weight: 57