MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Impaired Healing (2378); No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the system.Other relevant device(s) are: product id: 7482-51, serial/lot #:(b)(4) , ubd: (b)(6) 2014, udi#: (b)(4); product id: 3708660, serial/lot #:(b)(4) , ubd: (b)(6) 2018, udi#: (b)(4); product id: 3387-40, serial/lot #: (b)(4), ubd: (b)(6) 2014, udi#: (b)(4); product id: 3387-40, serial/lot #: (b)(4), ubd: (b)(6) 2014, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care provider (hcp) of a clinical study via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for unknown indications for use.The deep brain stimulation (dbs) system was explanted in (b)(6) 2017.There were no diagnostic/troubleshooting, nor contributing factors reported.The patient exited that study, so it was unknown if the system components were replaced.No patient symptoms were reported.No further complications were reported.

Manufacturer Narrative

Product id: 7482-51, serial# (b)(4), explanted: (b)(6) 2017, product type: extension; product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2017, product type: extension; product id: 3387-40, lot# 0204136338, implanted: (b)(6) 2010, explanted: (b)(6) 2017, product type: lead; product id: 3387-40, lot# 0204136338, implanted: (b)(6) 2010, explanted: (b)(6) 2017, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information clarified that the system was explanted due to wound healing disorder.No further complications were reported /anticipated.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7553692
• MDR Text Key: 109562431
• Report Number: 3004209178-2018-12144
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

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: 02/28/2013
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2018
• Initial Date FDA Received: 05/30/2018
• Supplement Dates Manufacturer Received: 05/30/2018
• Supplement Dates FDA Received: 05/31/2018
• Date Device Manufactured: 04/09/2012
• 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