MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA

Model Number 37602

Device Problems Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Material Deformation (2976)

Patient Problems Undesired Nerve Stimulation (1980); Dizziness (2194); Shaking/Tremors (2515); Electric Shock (2554)

Event Date 07/28/2021

Event Type  malfunction  

Event Description

It was reported that about 3 months ago, the patient was getting shocked, they were "real lightheaded and dizzy," and they would get "surges" where they had stimulation running through different parts of their body at different times, which was "really weird." the patient added that their tremors were also "really bad" during this time.The patient noted that all these symptoms occurred on both sides of their body.The patient confirmed that their healthcare provider (hcp) already addressed the issue and discovered that there was a problem with the "left lead." the patient attempted to clarify themselves and stated, "they're saying there's a kink in the line behind my ear." the patient also noticed that the left ins battery voltage has been stuck on 2.78 for 2 weeks, and they wondered if the left ins was possibly "shorted out." the patient noted that the right ins voltage was at2.55.The patient added that they could not turn the left ins on or off, and that it would not do anything at all.The patient confirmed that their hcp was handling the situation, and that they have an appointment with them next week.Refer to manufacturer report #3004209178-2021-17606.

Manufacturer Narrative

Concomitant medical products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2020, product type: implantable neurostimulator.Product id: 3387s-40, lot# v388841, product type: lead.Other relevant device(s) are: product id: 3387s-40, serial/lot #: (b)(4), ubd: 25-aug-2012, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• 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: 12872596
• MDR Text Key: 286771970
• Report Number: 3004209178-2021-17607
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00643169864207
• UDI-Public: 00643169864207
• 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: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2019
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2021
• Date Device Manufactured: 05/30/2018
• 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: 63 YR
• Patient Sex: Female