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

Model Number	SC-9004-55
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	02/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient experienced a loss of stimulation.The physician assessed the presence of high and low impedance readings on the leads.Attempts to reprogram the device were unsuccessful, and the patient underwent a revision procedure where the adaptors were removed and the non-boston scientific leads were replaced.The patient did well post-operatively.The devices were retained by the physician and were not returned for analysis.
Additional Manufacturer Narrative
Event date unknown.Additional suspect medical device components involved in the event: product family: scs-adapters, upn: m365sc9004550, model: sc-9004-55, serial: (b)(4), batch: 2000017066.

• Brand Name: PRECISION
• 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 14094490
• Report Number: 3006630150-2022-01616
• Device Sequence Number: 5669207
• Product Code: LGW
• UDI-Device Identifier: 08714729767541
• UDI-Public: 08714729767541
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2022

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 Expiration Date: 09/01/2018
• Device Model Number: SC-9004-55
• Device Catalogue Number: SC-9004-55
• Device Lot Number: 2000017066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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 Sex: Unknown