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

Model Number	SC-2158-50
Medical Device Problem Codes	High impedance (1291); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: approximated based on the date the procedure.Date of implant: (b)(6) 2011, exact date unknown.Additional suspect medical device component involved in the event: product family: scs-linear leads, upn: m365sc2158500, model: sc-2158-50, serial: (b)(4), batch: 14147787.
Event or Problem Description
It was reported that the patient was unable to achieve pain relief of the targeted pain area.The patient underwent an explant procedure of a lead due to inadequate stimulation caused by high impedances.
Additional Manufacturer Narrative
Block b3: approximated based on the date the procedure.Block d6a: date of implant (b)(6) 2011, exact date unknown.Additional suspect medical device component involved in the event: product family: scs-linear leads, upn: m365sc2158500, model: sc-2158-50, serial: (b)(6), batch: 14147787.
Event or Problem Description
It was reported that the patient underwent an explant procedure due to inadequate stimulation caused by high impedances.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block b3: approximated based on the date the procedure.Block d6a: date of implant (b)(6) 2011, exact date unknown.Additional suspect medical device component involved in the event: product family: scs-linear leads.Upn: m365sc2158500.Model: sc-2158-50.Serial: (b)(6).Batch: 14147787.Product family: scs-ipg-r.Upn: m365sc1110020.Model: sc-1110-02.Serial: (b)(6).Batch: 14286509.Device technical analysis: the returned ipg was analyzed and passed all tests performed, and exhibited normal device characteristics, no anomalies were found.The two involved leads were not returned for analysis; therefore, a technical analysis could not be performed.Labeling review: a labeling review was performed on the leads and the ipg instructions for use, ifu and there was no evidence that the devices were used in a manner inconsistent with the labeled indications.Investigation conclusion: based on all available information, engineers are not able to confirm the event of inadequate stimulation caused by high impedances of the leads, as they were not returned for analysis, and the ipg passed all tests and no anomalies were found.The conclusion is determined to be cause not established as an analysis of the leads and the ipg passed all test.
Event or Problem Description
It was reported that the patient was unable to achieve pain relief of the targeted pain area.The patient underwent an explant procedure of a lead due to inadequate stimulation caused by high impedances.It is unclear at to which of the two leads was explanted.The ipg, implantable pulse generator, was also explanted and returned, however it is unclear as to why the ipg was explanted.No further information has been obtained despite good faith efforts.

• Brand Name: LINEAR
• 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: 12444863
• Report Number: 3006630150-2021-05044
• Device Sequence Number: 3515470
• Product Code: LGW
• UDI-Device Identifier: 08714729767695
• UDI-Public: 08714729767695
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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,Followup
• Report Date (Section B): 11/17/2021

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: 03/01/2013
• Device Model Number: SC-2158-50
• Device Catalogue Number: SC-2158-50
• Device Lot Number: 14178435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 09/15/2021; 11/10/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 10/13/2021; 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2011
• 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: Female