MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 3389-40

Device Problems Shipping Damage or Problem (1570); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2019

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s): product id: 924256, lot#: 082220418a, product type: accessory, ubd: 23-jul-2021, udi#: (b)(4).Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp), via a manufacturing representative (rep), regarding a patient with an implantable neurostimulator (ins) for parkinson's disease.It was reported that during implant the hcp used a self-drilling screw from the stimloc kit but the screw wouldn't purchase into the patient's bone.The hcp believed the material is of poor quality and seemed soft.Another bone screw was used and had no issue.There were no environmental/external/patient factors reported to contribute to the issue.No patient symptoms were reported.No further complications were reported or anticipated with this event.Additional information received from the manufacturer¿s representative (rep) reported the device was going to be returned for analysis.No further complications were anticipated.

Manufacturer Narrative

Concomitant medical products: product id 924256, lot# 082220418a, product type accessory.Analysis revealed that the threads of the screw were damaged.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 8322175
• MDR Text Key: 136038482
• Report Number: 3007566237-2019-00316
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3389-40
• Device Catalogue Number: 3389-40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/04/2019
• Date Manufacturer Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 107