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

Model Number 37603

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 3387s-40 lot# (b)(4) serial# implanted: (b)(6) 2014 product type lead product id 3708660 lot# serial# (b)(4) implanted: (b)(6) 2014 product type extension product id 3708660 lot# serial# (b)(4) implanted: (b)(6) 2015 product type extension product id 3389s-40 lot# (b)(4) serial# implanted: (b)(6) 2015 product type lead product id 37603 lot# serial# (b)(6) 2015 implanted: (b)(ection 6) 2015 explanted: (b)(6) 2018 product type implantable neurostimulator.Other relevant device(s) are: product id: 3387s-40, serial/lot #: (b)(4), ubd: 16-apr-2016, udi#: (b)(4); product id: 3708660, serial/lot #: (b)(4), ubd: 16-sep-2017, udi#: (b)(4); product id: 3708660, serial/lot #: (b)(4), ubd: 17-jul-2019, udi#: (b)(4); product id: 3389s-40, serial/lot #: (b)(4), ubd: 20-aug-2018, udi#: (b)(4).

Event Description

It was reported that the patient stated that one of their wires came out that's why their device was replaced in 2018.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14743186
• MDR Text Key: 294515871
• Report Number: 3004209178-2022-07829
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00613994761071
• UDI-Public: 00613994761071
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2015
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2022
• Date Device Manufactured: 10/30/2013
• 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
• Patient Age: 84 YR
• Patient Sex: Female