MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number 37612

Device Problems Low impedance (2285); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Nervous System Problem (4426); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2022

Event Type  Injury  

Event Description

It was reported that the patient had a short circuit (low impedance) due to the chronic positioning of their dystonia.The continuous movement on the right-sided lead seemed to have caused a short circuit.The surgeon decided to explant, the shorted right-sided lead, as well as the left-sided lead to replace the leads.Circumstances that may have led to the issue include the patient tends to hit the head on the wheelchair.There is no longer a short on the lead and the issue has been resolved.

Manufacturer Narrative

Concomitant medical products: product id 3387s-40, lot# va2fg6t ,implanted: (b)(6) 2021, explanted: (b)(6) 2022, product type lead.Other relevant device(s) are: product id: 3387s-40, serial/lot #: va2fg6t, ubd: 12-may-2024, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13954389
• MDR Text Key: 288618563
• Report Number: 3004209178-2022-04013
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/30/2022

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: 09/28/2016
• 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: 03/18/2022
• Initial Date FDA Received: 03/30/2022
• Date Device Manufactured: 11/13/2015
• 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: 16 YR
• Patient Sex: Male