MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION FREELINK REMOTE CONTROL; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-5270
Medical Device Problem Codes	Mechanical Problem (1384); Power Problem (3010); Wireless Communication Problem (3283)
Health Effect - Clinical Codes	Device Overstimulation of Tissue (1991); Pain (1994); Discomfort (2330)
Date of Event	10/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced high electric shocks cyclically causing pain and discomfort throughout the day.The event began when the patients remote control (rc) screen went completely black, and then started beeping.The patient went to the hospital emergency unit where it was attempted to turn the stimulation off and discontinue connection between the rc and the spinal cord stimulation implantable pulse generator (ipg).However, pressure on any rc button caused overstimulation shocks and the red emergency button, which is used to stop any stimulation and turn the stimulation off was not responding.The suspect rc was moved to a distant location to stop communication while another rc was successfully linked to the ipg and able to reset the ipg which resolved the issue.The patient fully recovered and was released from the hospital.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: brand name: wavewriter alpha 16 upn: m365sc12160 model: sc-1216 serial: (b)(6) batch: 568236 remote control (rc) model sc-5270, serial (b)(6) : the returned rc was analyzed, and the allegation of the rc screen turning completely black and then started beeping was confirmed.The rc failed the functional test during the buttons exercise.An internal visual inspection revealed severe corrosion on both sides of the printed circuit board assembly of the rc due to liquid exposure, which made the rc unresponsive.The probable cause is unintended use error caused or contributed to the vent.The rc was likely exposed to liquid and-or to a cleanser.
Event or Problem Description
It was reported that the patient experienced high electric shocks cyclically causing pain and discomfort throughout the day.The event began when the patients remote control (rc) screen went completely black, and then started beeping.The patient went to the hospital emergency unit where it was attempted to turn the stimulation off and discontinue connection between the rc and the spinal cord stimulation implantable pulse generator (ipg).However, pressure on any rc button caused overstimulation shocks and the red emergency button, which is used to stop any stimulation and turn the stimulation off was not responding.The suspect rc was moved to a distant location to stop communication while another rc was successfully linked to the ipg and able to reset the ipg which resolved the issue.The patient fully recovered and was released from the hospital.

• Brand Name: FREELINK REMOTE CONTROL
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 17930728
• Report Number: 3006630150-2023-06210
• Device Sequence Number: 20433352
• Product Code: LGW
• UDI-Device Identifier: 08714729995180
• UDI-Public: 08714729995180
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: SC-5270
• Device Catalogue Number: SC-5270
• Device Lot Number: 476405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2023
• Supplement Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 12/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male