MAUDE Adverse Event Report: MAINSTAY MEDICAL LIMITED REACTIV8

Model Number 5100 / 8145

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

Patient Problem Cramp(s) /Muscle Spasm(s) (4521)

Event Date 02/01/2024

Event Type  Injury  

Manufacturer Narrative

Mml ref # (b)(4).Patient information has been requested.B2-other: muscle spasm.Devices description: model: 5100 description: implantable pulse generator (ipg) serial number: (b)(6).Model: 8145 description: implantable stimulation lead serial numbers: (b)(6).

Event Description

It was reported that the patient had muscle spasms in october 2023 after starting physical therapy.The therapy manager advised the patient to take a break from stimulation therapy until his back settled down.A month later, the patient reported starting a ketamine infusion therapy regime and had noticed having more back spasms.The patient was instructed not to restart the therapy session until the spasm subsided.The patient had not used the therapy since october 2023 and continued to experience constant random contractions in his lateral muscles posteriorly and core muscles anteriorly.It was decided to explant the reactive system as it has not been in use so the patient, could have a magnetic resonance imaging (mri) done.The device has not been used since october 2023.It is unclear if the device has any relationship or contributed to the muscle spasm experienced by the patient.The explant was successful, with no report of patient harm or injury.The device was returned, and the implantable pulse generation (ipg) investigation revealed no leakage.The investigation is ongoing.

Event Description

It was reported that the patient had muscle spasms in october 2023 after starting physical therapy.The therapy manager advised the patient to take a break from stimulation therapy until his back settled down.A month later, the patient reported starting a ketamine infusion therapy regime and had noticed having more back spasms.The patient was instructed not to restart the therapy session until the spasm subsided.The patient had not used the therapy since october 2023 and continued to experience constant random contractions in his lateral muscles posteriorly and core muscles anteriorly.It was decided to explant the reactiv8 system as it has not been in use so the patient, could have a magnetic resonance imaging (mri) done.The device has not been used since october 2023.The explant was successful, with no report of patient harm or injury.The device was returned, and the implantable pulse generation (ipg) investigation revealed no leakage.

Manufacturer Narrative

Mml ref # (b)(4) b2-other: muscle spasm.The device was evaluated, including a review of the device log.No observation or anomaly was found that could have contributed to the customer's muscle spasm.The doctor reported that the patient is doing physical therapy to help reduce spasm and dystonia.The patient is also getting bone injections to treat the dystonia.Although requested, the patient demographic information is not available.E1 was corrected.B5 and h6 were updated.

• Brand Name: REACTIV8
• Type of Device: REACTIV8
• Manufacturer (Section D): MAINSTAY MEDICAL LIMITED; clonmel house, forster way; swords, dublin K67F2 ; EI K67F2
• Manufacturer Contact: liza dominguez ; 6601 shingle creek parkway; suite 200; brooklyn center, MN 55430 ; 6192063331
• MDR Report Key: 18822866
• MDR Text Key: 336734287
• Report Number: 3013017877-2024-00009
• Device Sequence Number: 1
• Product Code: QLK
• UDI-Device Identifier: 05391527770015
• UDI-Public: (01)05391527770015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5100 / 8145
• Device Catalogue Number: 5100 / 8145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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 Sex: Male