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

Model Number	SC-1112
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Charging Problem (2892); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Pain Relief (2388)
Date of Event	10/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing inadequate stimulation and charging difficulties of their implantable pulse generator (ipg).The physician assessed that the ipg had tilted and the patient underwent an ipg revision procedure.The patient is doing well post-operatively.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: unk; upn: unk; model: unk; serial: unk; batch: unk.Product family: unk; upn: unk; model: unk; serial: unk; batch: unk.
Event or Problem Description
It was reported that the patient was experiencing inadequate stimulation and charging difficulties of their implantable pulse generator (ipg).The physician assessed that the ipg had tilted and the patient underwent a revision procedure.The patient is doing well post-op.
Additional Manufacturer Narrative
Correction to initial mdr in block: h6.Investigation summary: with all available information, boston scientific concludes that the reported event of inadequate stimulation and charging difficulties was most likely the result of ipg (implantable pulse generator) migration as documented in the instructions for use (ifu).Investigation conclusion: review of the devices manufacturing documentation confirmed that this ipg passed all required specifications and testing prior to being released for distribution/sale.With the laboratory analysis and the labeling review, it has been determined that the inadequate stimulation and charging difficulties were likely a result of ipg migration which is a known inherent risk with use of the ipg as documented in the ifu.

• 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: 12841482
• Report Number: 3006630150-2021-06565
• Device Sequence Number: 17250702
• Product Code: LGW
• UDI-Device Identifier: 08714729837138
• UDI-Public: 08714729837138
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2022

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: 01/31/2017
• Device Model Number: SC-1112
• Device Catalogue Number: SC-1112
• Device Lot Number: 17556709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2015
• 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