MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA

Model Number 37603

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Fluid Discharge (2686)

Event Date 10/07/2021

Event Type  Injury  

Event Description

It was reported that the patient bumped his head on the wall when going down the stairs at home.After a few days he felt there was some wetness on his scalp and his wife looked at it and there was a scab that was oozing over the lead insertion site.They reported this to the provider and they were referred to wound center to get cream to help with the healing process.  two weeks passed and he was reassessed  and it was determined that he needed to have the left deep brain system removed.He still has an open wound with the lead/burr hole device exposed.There are no signs or symptoms of infection but the doctor wants to remove it to prevent infection from occurring.Patient has bilateral systems and the right one will remain in place.

Manufacturer Narrative

Concomitant products: product id: 3389s-40, lot#: va0n9tf, implanted: (b)(6) 2014, explanted: (b)(6) 2021, product type: lead.Product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2021, product type: extension.Other relevant device(s) are: product id: 3389s-40, serial/lot #: (b)(4), ubd: 14-jul-2017, udi#: (b)(4); product id: 3708660, serial/lot #: (b)(4), ubd: 07-oct-2018, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12872748
• MDR Text Key: 281272051
• Report Number: 3004209178-2021-17609
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864214
• UDI-Public: 00643169864214
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/24/2021

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: 11/14/2020
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 11/24/2021
• Date Device Manufactured: 05/21/2019
• 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: 71 YR
• Patient Sex: Male