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

Model Number 37603

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

Patient Problems Erosion (1750); Skin Erosion (2075)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 3389s-40, lot#: va1ukuq, implanted: (b)(6) 2019, product type: lead.Product id: neu_burrholecap, serial# unknown, product type: accessory.Product id: 3708660, serial#: (b)(4), product type: extension.Other relevant device(s) are: product id: neu_burrholecap, serial/lot#: unknown.Product id: 3389s-40, serial/lot #: (b)(4), ubd: 02-jul-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a manufacturing representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported that the patient had erosion over the right and left sides of their scalp directly over their burr hole caps.Both burr hole covers were showing through the skin.The patient acknowledged they had been picking at their wound over both burr hole covers.The patient was referred to their neurosurgeon; the issue was not considered resolved at the time of the report.Additional information received from the manufacturer¿s representative (rep) reported the physician removed the entire left side of the dbs system on (b)(6) 2021.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 12828886
• MDR Text Key: 280895549
• Report Number: 3004209178-2021-17176
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2020
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Date Device Manufactured: 04/12/2019
• 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: 68 YR
• Patient Sex: Female