MAUDE Adverse Event Report: MAINSTAY MEDICAL LIMITED REACTIV8; REACTIV8 IMPLANTABLE PULSE GENERATOR, PRODUCT

Model Number 5100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Implant Pain (4561)

Event Date 12/01/2023

Event Type  Injury  

Manufacturer Narrative

Mml reference #: (b)(4).B2-other: pain/discomfort other devices explanted model: 8145 description: implantable stimulation lead serial numbers: (b)(6).

Event Description

It was reported that the patient had lost weight and now experienced pocket pain and discomfort at the implantable pulse generator (ipg) pocket and requested an explant.The patient was implanted with the reactiv8 system in 2016 but has stopped using the device since 2018.The device was removed and intact.There was no report of patient harm or injury.The device was returned and evaluated.The implantable pulse generator (ipg) and one lead passed the functional test.Although there was no allegation against the device's function, one lead was observed with the coil wire broken.

Event Description

It was reported that the patient had lost weight and now experienced pocket pain and discomfort at the implantable pulse generator (ipg) pocket and requested an explant.The patient was implanted with the reactive system in 2016 but has stopped using the device since 2018.The device was removed and intact.There was no report of patient harm or injury.The device was returned and evaluated.The implantable pulse generator (ipg) and one lead passed the functional test.Although there was no allegation against the device's function, one lead was observed with the coil wire broken.

Manufacturer Narrative

Mml reference #: (b)(4).B2-other: pain/discomfort other devices explanted model: 8145 description: implantable stimulation lead serial numbers: (b)(6).Updated the serial number above.Missing a digit.Additonal information: visual inspection of the ipg found no non-conformances that would have contributed to the discomfort experienced by the patient.The possible root cause was that the ipg moved against tissue, which irritated the surrounding tissue due to the patient's weight loss.

• Brand Name: REACTIV8
• Type of Device: REACTIV8 IMPLANTABLE PULSE GENERATOR, PRODUCT
• Manufacturer (Section D): MAINSTAY MEDICAL LIMITED; clonmel house, forster way; swords, county dublin K67F2 ; EI K67F2
• Manufacturer Contact: liza dominguez ; 6601 shingle creek parkway; suite 200; brooklyn center, MN 55430 ; 6192063331
• MDR Report Key: 18422684
• MDR Text Key: 331664985
• Report Number: 3013017877-2023-00058
• Device Sequence Number: 1
• Product Code: QLK
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P190021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5100
• Device Catalogue Number: 5100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2016
• 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): Other
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Race: White