MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE ELECTRICAL LEAD; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number NEU_UNKNOWN_LEAD

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

The main component of the system.Other relevant device(s) are: product id: neu_stimloc_acc.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturing representative about a patient with an implantable electrical lead for unknown indications for use.It was reported that during the lead implant procedure the physician had a difficult time fixing the burr hole cover screws into the bone.The tapping screws could not take the bone.A screw was broken and remained inside the bone.The neurosurgeon opened 3 boxes of burr hole covers to try more screws.The surgeon was convinced it was a problem with the bone.A fourth box was opened and they were able to screw in the screws making a small entry hole first.The procedure was completed with success.It was unknown if there were any external or environmental factors that led to the event.There were no symptoms reported.No further complications were reported or anticipated.

Manufacturer Narrative

Other applicable components are: product id: 924256, lot# 082228317a, product type: accessory; product id: 924256, lot# 082228317a, product type: accessory; product id: 924256, lot# 082228317a, product type: accessory; product id: 924256, lot# 082228317a, product type: accessory.If information is provided in the future, a supplemental report will be issued.

Event Description

Device information was provided.

Manufacturer Narrative

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

• Brand Name: UNKNOWN IMPLANTABLE ELECTRICAL LEAD
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7641649
• MDR Text Key: 112458915
• Report Number: 3007566237-2018-01906
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_UNKNOWN_LEAD
• Device Catalogue Number: NEU_UNKNOWN_LEAD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• 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