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

Model Number 37612

Device Problems Break (1069); Low impedance (2285); Device Operates Differently Than Expected (2913); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

Continuation of medical devices: product id 3389s-40 lot# va1bf2d implanted: (b)(6) 2017 explanted: (b)(6) 2018 product type lead.Product id 3389s-40, lot# v248458, implanted: (b)(6) 2009, product type lead.Product id 3708660m serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2018 product type extension.Product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type extension.Product id 3389s-40, lot# v248458, implanted: (b)(6) 2009, product type lead.Information references the main component of the system.Other relevant device(s) are: product id: 3389s-40, serial/lot #: (b)(4), ubd: 25-jul-2019, udi#: (b)(4); product id: 3389s-40, serial/lot #: (b)(4), ubd: 17-dec-2011, udi#: (b)(4); product id: 3708660, serial/lot #: (b)(4), ubd: 12-dec-2020, udi#: (b)(4); product id: 3708660, serial/lot #: (b)(4), ubd: 03-feb-2018, udi#: (b)(4); product id: 3389s-40, serial/lot #: (b)(4), ubd: 17-dec-2011, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional via a manufacturer representative regarding a patient who was implanted with a neurostimulator (ins).It was reported the patient was getting his hair cut on (b)(6) 2018 and the hairdresser caught the edge of the boot with the hairbrush dislocating it.The patient reported he could "feel the edge of something".The next day he was brushing his hair and caught the boot on the right side with the hairbrush and it ripped out.The boot with the ends of the lead and extension was accidently torn from the patient's head.The left connection was also damaged, showing low impedances for contacts 2<(>&<)>3.The surgeon examined the site and reported the patient was not a candidate for further surgery.The right side was no longer functional so it was turned off.The left side was programmed around contacts 2<(>&<)>3.The issue was not resolved at the time of the report.No surgical intervention occurred or was planned.The patient was alive without injury at the time of the report.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is complete.Product id 3389s-40, (lot# va1bf2d) and product id 3708660, (serial# (b)(4)) were returned.Fdc (b)(4) no longer applies for these products.Fdc (b)(4) now applies.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturing representative indicating that the cause was due to being caught by a brush and ripped from his head while the patient was combing his hair.The issue is not yet resolved.This information was confirmed by the physician.

Manufacturer Narrative

Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.Analysis of the lead (lot# va1bf2d) revealed that the lead was broken (overstress/damaged) at the proximal end of the conductor.Analysis of the extension (serial # (b)(4)) revealed that the extension was broken (overstress/damage) at the distal end of the conductor.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 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: 7583728
• MDR Text Key: 110587698
• Report Number: 3004209178-2018-13009
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994934611
• UDI-Public: 00613994934611
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/28/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2015
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 06/08/2018
• Supplement Dates Manufacturer Received: 06/11/2018; 06/12/2018; 08/22/2018
• Supplement Dates FDA Received: 06/13/2018; 06/19/2018; 08/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2014
• 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 Age: 66 YR