Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAINSTAY MEDICAL LIMITED REACTIV8; REACTIVE IMPLANTABLE PULSE GENERATOR (IPG)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAINSTAY MEDICAL LIMITED REACTIV8; REACTIVE IMPLANTABLE PULSE GENERATOR (IPG) Back to Search Results
Model Number 5100
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Implant Pain (4561)
Event Date 01/12/2023
Event Type  Injury  
Event Description
It was reported that the patient experienced wear discomfort at the implantable pulse generator (ipg) pocket site.The surgeon explanted the device with no report of patient harm or injury.Reportedly, the patient benefited from the therapy and was doing well.Unrelated to the reported discomfort issue, it was reported that the therapy started without activation with the remote.The clinical specialist reviewed the device log.There was no indication in the device log that the therapy started without an activation.The activation issue was not verified.
 
Manufacturer Narrative
Pain/discomfort.The patient has been using the device for more than four years and has benefitted from the therapy.Mml reference # (b)(4).
 
Manufacturer Narrative
B2 other: pain/discomfort.Mml reference # (b)(4).4/11/2023.The patient has been implanted with the reactiv8 system for over four years.The patient reported he has benefited from the therapy and is pain-free.Although the patient was 100% responding to the therapy, he continued to use the device for therapy.Further communication was received from the patient and mainstay medical representative that the patient requested an explant due to the wear discomfort under the belt area.The manufacturing record of this device was reviewed, and no relevant nonconformances were found.Per the reactv8 system implant and programming manual, a known risk associated with surgery, implantation of a medical device, or use of reactiv8 is acute or persistent pain and/or discomfort due to the presence of the device.The device was returned and evaluated.No observation was found that would have contributed to the wear discomfort reported by the patient.Updated h6 codes.
 
Event Description
It was reported that the patient experienced wear discomfort at the implantable pulse generator (ipg) pocket site.The surgeon explanted the device with no report of patient harm or injury.Reportedly, the patient benefited from the therapy and was doing well.Unrelated to the reported discomfort issue, it was reported that the therapy started without activation with the remote.The clinical specialist reviewed the device log.There was no indication in the device log that the therapy started without an activation.The activation issue was not verified.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
REACTIV8
Type of Device
REACTIVE IMPLANTABLE PULSE GENERATOR (IPG)
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 Key16356935
MDR Text Key309322996
Report Number3013017877-2023-00005
Device Sequence Number1
Product Code QLK
UDI-Device Identifier05391527770008
UDI-Public(01)05391527770008
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P190021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number5100
Device Catalogue Number5100
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received03/13/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/06/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age56 YR
Patient SexMale
Patient Weight78 KG
-
-