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

Model Number 5100

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

Patient Problem Implant Pain (4561)

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported that the patient fell down the spiral staircase at home and landed on her implantable pulse generator (ipg) in (b)(6) 2022.The patient reported excruciating pain, tenderness on and above the ipg.A doctor saw the patient and confirmed the ipg site was tender, and inflamed.The doctor believes the cluneal nerves above the ipg have flared up.The doctor performed an ablation procedure to relieve the pain and inflammation.The specific date of the ablation procedure was not provided to mainstay medical but it noted it was done about seven weeks after the patient fall incident.

Manufacturer Narrative

Mml ref (b)(4).B2: other -ablation procedure due to patient fall incident.B3: actual date of event was not provided.Facility contact number: (b)(6).

Manufacturer Narrative

Mml ref (b)(4).B2: other -ablation procedure due to patient fall incident.B3: actual date of event was not provided.Facility contact number: (b)(6).It was reported that the patient had no further issues after the ablation procedure.The device manufacturing record was reviewed.There are no nonconformances found during the manufacturing process of the ipg.

Event Description

It was reported that the patient fell down the spiral staircase at home and landed on her implantable pulse generator (ipg) in (b)(6) 2022.The patient reported excruciating pain, tenderness on and above the ipg.A doctor saw the patient and confirmed the ipg site was tender, and inflamed.The doctor believes the cluneal nerves above the ipg have flared up.The doctor performed an ablation procedure to relieve the pain and inflammation.The specific date of the ablation procedure was not provided to mainstay medical but it noted it was done about seven weeks after the patient fall incident.

• Brand Name: REACTIV8
• Type of Device: REACTIV8 IMPLANTABLE PULSE GENERATOR
• 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: 17056684
• MDR Text Key: 316479348
• Report Number: 3013017877-2023-00021
• Device Sequence Number: 1
• Product Code: QLK
• UDI-Device Identifier: 05391527770015
• UDI-Public: 0105391527770015
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P190021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/02/2021
• 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: 49 YR
• Patient Weight: 106 KG