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

Model Number 37603

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

Patient Problems Bruise/Contusion (1754); Injury (2348); Post Operative Wound Infection (2446)

Event Date 05/18/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 37603, serial (b)(4), product type: implantable neurostimulator.Product id: 3389-28, product type: lead.Product id: 3389-28, product type: lead.Product id: 3708660, product type: extension.Product id: 3708660, product type: extension.(b)(4).

Event Description

Information was received from a healthcare professional of a clinical study which reported that the wound location had been hit multiple times, was bruised and afterward there was an infection in the same place.There was a wound infection.Antibiotics had not improved it and the left side system, implantable neurostimulator (ins) was removed.The patient had to be hospitalized or had to stay longer for treatment.This was not related to the neurostimulator, left side system or lead.The outcome was recovered.Patient's medical history included secondary dystonia due to anti psychotic drugs, depression and emotionally unstable.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported it was unknown if the lead was related to the event.The patient had previous bruises, not an adverse event, due to symptom since before the procedure, along with pre-surgical symptoms.An area along the wound site bruise had flared and wound dehiscence was observed along with reddening and wound disruption.The relationship between the bruise and the wound dehiscence/infection/wound disruption is unknown.There was no worsening or deterioration noted.The system was not replaced.

Event Description

Additional information received reported there were no remarkable abnormalities in medical device or deep brain stimulation therapy.

• 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: 5309796
• MDR Text Key: 33843941
• Report Number: 3004209178-2015-25271
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2016
• Date Device Manufactured: 01/29/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 00045 YR