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

Model Number 37603

Device Problems Activation, Positioning or Separation Problem (2906); Insufficient Information (3190)

Patient Problem Muscular Rigidity (1968)

Event Date 07/08/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3708660, serial #: (b)(4), implanted: (b)(6) 2019, product type: extension.Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(4), ubd: 13-nov-2022, udi #: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported the electrodes were implanted on (b)(6) 2019 and the electrical leads and control devices were implanted in the chest on (b)(6) 2019.The issue began (b)(6) 2019.It was reported the wire that ran from the electrode in the head to the control device in the chest was too tight on the right side.The physician had trouble "getting a clean route".The patient complained during a doctor's visit.On (b)(6) 2019 one electrical lead on the right side was replaced.The patient was feeling better but still felt slightly tight in the mornings but better overall.The patient was generally feeling good.The tremors were under control.The patient was returning to the doctor's office on (b)(6) 2019 to remove the staples.

• 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: 8817331
• MDR Text Key: 151917384
• Report Number: 3004209178-2019-14060
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864214
• UDI-Public: 00643169864214
• 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
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2020
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2019
• Date Device Manufactured: 03/20/2019
• 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: 72 YR
• Patient Weight: 100