MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CLINICIAN PROGRAMMER; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	NM-7164
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date: approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
A report was received that the patient was receiving adequate stimulation following a postoperative reprogramming.However, after the bsn sales representative removed her hands from the clinician programmer (cp), the patient started yelling for the bsn sales representative to turn it off the stimulation.The bsn sales representative observed that the cp amplitude had more than doubled and quickly turned off the cp.The patient reported that the overstimulation caused a flare in her complex regional pain syndrome (crps) and she experienced extreme pain along with arm and hand convulsions.The physician examined the patient and confirmed the patient was stable enough to continue with the reprogramming session.A follow up with the patient revealed that the patient was still experiencing a flare up of her crps and she was apprehensive about turning the stimulation back on.The patient reported that she was unable to leave her house due to the incident, and that she was meeting with a physical therapist.
Additional Manufacturer Narrative
Nm-7164 sn: (b)(6).The returned clinician programmer was analyzed, passed all tests performed, and exhibited normal device characteristics.The reported event was not confirmed.Therefore no problem was detected.
Event or Problem Description
It was reported that the patient was shaking and crying as it felt as though the patient was electrocuted following a reprogramming session.The patient was in horrific pain with arm and hand convulsions.The incident was reported to the physician and the sales representative explained that it was a software malfunction or the a button on the keyboard she was using to increase amplitude was stuck unintentionally causing the increased in stimulation.The clinician programmer was immediately turned off.

• Brand Name: CLINICIAN PROGRAMMER
• 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: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 14553252
• Report Number: 3006630150-2022-02619
• Device Sequence Number: 20104498
• Product Code: LGW
• UDI-Device Identifier: 08714729991212
• UDI-Public: 08714729991212
• Combination Product (Y/N): N
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2022

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: NM-7164
• Device Catalogue Number: NM-7164
• Device Lot Number: 25677759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female