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 Wound Dehiscence (1154); Purulent Discharge (1812); Unspecified Infection (1930); Ulcer (2274); Fluid Discharge (2686); Test Result (2695)

Event Date 01/17/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) of a clinical study regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported there was a dehisced incisional wound at the right shoulder ins incision site.The issue was resolved without sequelae on (b)(6) 2019.The patient was on a course of antibiotics for 10 days - bactrim starting (b)(6) 2019.It was noted there was other surgical intervention, as sharp tissue excisional debridement of the right shoulder ulcer at the incision site.It was noted, however, the procedure was not related to the device.It was indicated the event was unrelated to the device/therapy, but it was related to the implant procedure.Symptoms were noted as some pus-like formation at right shoulder generator surgical site,.Drained some white thick matter even after course of antibiotics for ten days.Debridement of ulcer for removal necrotic tissue.An infection was suspected at the incision site, cbc, esr, and crp were little elevated.No further complications were reported.

• 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8752424
• MDR Text Key: 149763988
• Report Number: 3004209178-2019-12758
• 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,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2019
• Date Device Manufactured: 10/04/2018
• 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): Other; Required Intervention
• Patient Age: 41 YR