MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37602

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 3389-28, product type: lead.Product id: 3389-28, product type: lead.Product id: 7482, product type: extension,.Product id: 7482, product type: extension.(b)(4).

Event Description

A healthcare provider (hcp) for a clinical study reported via a manufacturer representative that on (b)(6) 2014, the patient had an onset of pain and flare/redness at the implantable neurostimulator (ins) implantation site in the chest was observed.Before long an abscess was formed.On (b)(6) 2015, the ins and the extension were removed.The patient had to be hospitalized.After waiting for the infection to be cured, re-implantation was performed on (b)(6) 2015, and the patient recovered.The cause of the infection could not have been determined.The patient was enrolled in a clinical study for dystonia.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received from the healthcare professional of a clinical study reported that the area around the implantable neurostimulator (ins) was the core of the eczema, so it was determined that there was a causal relationship.

Manufacturer Narrative

Concomitant medical products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 3389-28, product type: lead.Product id: 3389-28, product type: lead.Product id: 7482, product type :extension.Product id: 7482, product type: extension.(b)(4).

Event Description

Additional information received reported that there was no implantable neurostimulator (ins) or implant site anomaly.The cause of infection was determined to be phlogogenic fungus/ (b)(6) by cultivation survey or other tests.Tumor occurred mainly around the ins and it was considered that there was causality.Other actions included cefazolin sodium infusion.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• 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: 5025729
• MDR Text Key: 23905521
• Report Number: 3004209178-2015-16612
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 07/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2015
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2015
• Date Device Manufactured: 04/30/2014
• 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: 00021 YR