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 Problem Unspecified Infection (1930)

Event Date 03/20/2015

Event Type  Injury  

Event Description

It was reported that the lead was removed for some type of infection in the brain.The infection had occurred on (b)(6) prior to the date of this report.The healthcare professional was inquiring about an mri with only the extension and implantable neurostimulator (ins) in place.No outcome was provided.Further follow-up is being conducted to obtain this information.If additional information is received a supplemental report will be submitted.

Manufacturer Narrative

Concomitant medical products: product id: unknown, serial# unknown, product type: extension.Product id: 3389s-40, lot# va0qbqv, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead.(b)(4).

Manufacturer Narrative

Concomitant medical products: product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: extension.Product id: 3389s-40, lot# va0qbqv, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead.The initial mdr was filed as manufacturing report #3007566237-2015-01344.Additional review showed the correct manufacturing site was site #(b)(4).

Event Description

Additional information received from the healthcare provider (hcp) reported that the patient had an infection and the lead and extension were removed on (b)(6) 2015.Only the battery was left in the patient's body.The patient had not received a new battery as of (b)(6) 2015.

• 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 MN 00777 1200
• 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: 4778649
• MDR Text Key: 5802319
• Report Number: 3007566237-2015-01344
• 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: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2016
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2015
• Date Device Manufactured: 09/18/2014
• 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: 00068 YR