MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Infinion? 16; Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Model Number	SC-2316-50
Medical Device Problem Codes	High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146)
Date of Event	10/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model number/catalog number: sc-2316-50.Serial number:(b)(6).Batch/lot number: 7081323.Model/catalog description: infinion 16 lead kit 50 cm.Unique identifier (udi) #: (b)(4).Model number/catalog number: sc-1432.Serial number: (b)(6).Batch/lot number: 202953.Model/catalog description: wavewriter alpha prime 32 ipg kit.Unique identifier (udi) #: (b)(4).Model number/catalog number: sc-2316-50.Serial number:(b)(6).Batch/lot number: 7072118.Model/catalog description: infinion 16 lead kit 50 cm.Unique identifier (udi) #: (b)(4).
Event or Problem Description
The lead was reported to have migrated and exhibited high impedance levels.The patient experienced unwanted stimulation, including burning sensations and pain localized at the battery site.Programming optimization was attempted but did not resolve the issue.Patient was working with the office to get approval with insurance for a revision.
Additional Manufacturer Narrative
Sc-2316-50 (sn (b)(6).Investigation result: the device was not returned to boston scientific for analysis.Device history record: a review of the device history record (dhr) confirmed the device met all specifications prior to shipping, with no manufacturing deviations identified that could have contributed to the reported event.Labeling review: the product labeling indicates that the following may be potential risks associated with the use of spinal cord stimulation (scs) therapy: system failure, which can occur at any time due to random failure(s) of the components or the battery.These events, which may include device failure, lead breakage, hardware malfunctions, loose connections, electrical shorts or open circuits and lead insulation breaches, can result in ineffective pain control.Undesirable stimulation may occur over time due to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections and/or lead failure and lead migration, resulting in undesirable changes in stimulation and subsequent reduction in pain relief.Labeling also states: heat due to charging (for rechargeable ipgs).Patients should not charge while sleeping.This may result in a burn.While charging, the charger may become warm.It should be handled with care.Failure to use the charger with either the charging belt or an adhesive patch, may result in a burn.If patients experience pain or discomfort, they should cease charging and contact boston scientific.Risk review: a risk review was completed and confirmed that the event of applicable migration, impedance high, over stimulation caused by leads was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, an investigation conclusion code of cause not established was assigned to the investigation for all components.Additional suspect medical device component involved in the event: model number/catalog number: sc-2316-50 serial number:(b)(6) batch/lot number: 7081323 model/catalog description: infinion 16 lead kit 50 cm unique identifier (udi) #: (b)(4).Model number/catalog number: sc-1432 serial number: (b)(6) batch/lot number: 202953 model/catalog description: wavewriter alpha prime 32 ipg kit unique identifier (udi) #: (b)(4).Model number/catalog number: sc-2316-50 serial number:(b)(6) batch/lot number: 7072118 model/catalog description: infinion 16 lead kit 50 cm unique identifier (udi) #: (b)(4).Sc-2316-50 (sn (b)(6).Investigation result: the device was not returned to boston scientific for analysis.Device history record: a review of the device history record (dhr) confirmed the device met all specifications prior to shipping, with no manufacturing deviations identified that could have contributed to the reported event.Labeling review: the product labeling indicates that the following may be potential risks associated with the use of spinal cord stimulation (scs) therapy: lead migration, resulting in undesirable changes in stimulation and subsequent reduction in pain relief.Undesirable stimulation may occur over time due to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections and/or lead failure and persistent pain at the ipg or lead site.Risk review: a risk review was completed and confirmed that the event of migration was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.Sc-1432 (sn (b)(6).Investigation result: the device was not returned to boston scientific for analysis.Device history record: a review of the device history record (dhr) confirmed the device met all specifications prior to shipping, with no manufacturing deviations identified that could have contributed to the reported event.Labeling review: the product labeling indicates that the following may be potential risks associated with the use of spinal cord stimulation (scs) therapy: "system failure, which can occur at any time due to random failure(s) of the components or the battery.These events, which may include device failure, lead breakage, hardware malfunctions, loose connections, electrical shorts or open circuits and lead insulation breaches, can result in ineffective pain control." and "persistent pain at the ipg or lead site.Risk review: a risk review was completed and confirmed that the event of over stimulation caused by was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.Sc-2316-50 (sn (b)(6).Investigation result: the device was not returned to boston scientific for analysis.Device history record: a review of the device history record (dhr) confirmed that the device met specifications prior to shipping.No manufacturing deviations were noted that could have contributed to the event reported.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
The lead was reported to have migrated and exhibited high impedance levels.The patient experienced unwanted stimulation, including burning sensations and pain localized at the battery site.Programming optimization was attempted but did not resolve the issue.Patient was working with the office to get approval with insurance for a revision.
Event or Problem Description
The lead was reported to have migrated and exhibited high impedance levels.The patient experienced unwanted stimulation, including burning sensations and pain localized at the battery site.Programming optimization was attempted but did not resolve the issue.Patient was working with the office to get approval with insurance for a revision.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model number/catalog number: sc-2316-50 serial number:(b)(6) batch/lot number: 7081323 model/catalog description: infinion 16 lead kit 50 cm unique identifier (udi) #:(b)(4) model number/catalog number: sc-1432 serial number: (b)(6) batch/lot number: 202953 model/catalog description: wavewriter alpha prime 32 ipg kit unique identifier (udi) #: (b)(4) model number/catalog number: sc-2316-50 serial number:(b)(6) batch/lot number: 7072118 model/catalog description: infinion 16 lead kit 50 cm unique identifier (udi) #: (b)(4) sc-2316-50 (sn (b)(6).Investigation result: the device was not returned to boston scientific for analysis.Device history record: a review of the device history record (dhr) confirmed the device met all specifications prior to shipping, with no manufacturing deviations identified that could have contributed to the reported event.Labeling review: the product labeling indicates that the following may be potential risks associated with the use of spinal cord stimulation (scs) therapy: lead migration, resulting in undesirable changes in stimulation and subsequent reduction in pain relief.Undesirable stimulation may occur over time due to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections and/or lead failure and persistent pain at the ipg or lead site.Risk review: a risk review was completed and confirmed that the event of migration was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.Sc-1432 (sn (b)(6).Investigation result: the device was not returned to boston scientific for analysis.Device history record: a review of the device history record (dhr) confirmed the device met all specifications prior to shipping, with no manufacturing deviations identified that could have contributed to the reported event.Labeling review: the product labeling indicates that the following may be potential risks associated with the use of spinal cord stimulation (scs) therapy: "system failure, which can occur at any time due to random failure(s) of the components or the battery.These events, which may include device failure, lead breakage, hardware malfunctions, loose connections, electrical shorts or open circuits and lead insulation breaches, can result in ineffective pain control." and "persistent pain at the ipg or lead site.Risk review: a risk review was completed and confirmed that the event of over stimulation caused by was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.Sc-2316-50 (sn (b)(6).Investigation result: the device was not returned to boston scientific for analysis.Device history record: a review of the device history record (dhr) confirmed that the device met specifications prior to shipping.No manufacturing deviations were noted that could have contributed to the event reported.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• Brand Name: Infinion? 16
• Common Device Name: Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): Boston Scientific Corporation; road 698, lot no. 12; dorado PR 00646 -260; PR 00646-2602
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 25272480
• Report Number: 3006630150-2026-03452
• Device Sequence Number: 21258589
• Product Code: LGW
• UDI-Device Identifier: 08714729797814
• UDI-Public: (01)08714729797814(17)211208(10)7081317
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/01/2026

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: 12/08/2021
• Device Model Number: SC-2316-50
• Device Catalogue Number: SC-2316-50
• Device Lot Number: 7081317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Supplement Date Received by Manufacturer: 06/12/2026; 07/10/2026; 09/08/2026
• Initial Report FDA Received Date: 05/25/2026
• Supplement Report FDA Received Date: 07/06/2026; 08/04/2026; 10/01/2026
• Date Device Manufactured: 12/09/2019
• 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: 57 YR
• Patient Sex: Male