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

Model Number	SC-9208-15
Medical Device Problem Codes	Off-Label Use (1494); Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: brand name: precision; upn: m365sc9208150; model: sc-9208-15; serial: (b)(4); batch: (b)(4).
Event or Problem Description
It was reported that the patient who was implanted with a competitors leads and boston scientific adaptors, experienced mild electric shocks throughout the entire body, and experienced inadequate stimulation.Troubleshooting was performed but the issue persisted.The patient underwent a revision procedure, however prior to the surgery, the physician could trigger the electric shocks by pressing on the header of the implantable pulse generator, ipg, where the adaptor cables come out.After the ipg pocket was opened, the physician could no longer trigger the shocks anymore.Nevertheless, the physician decided to replace both adaptors with new ones.The patient was doing fine post-operatively.
Event or Problem Description
It was reported that the deep brain stimulation, dbs patient, who was implanted with non-boston scientific deep brain stimulation, dbs leads and boston scientific spinal cord stimulation, scs lead adaptors, experienced inadequate stimulation and mild electric shocks throughout the entire body.There were no impedances found during an impedance check, however, the physician was able to trigger the electric shocks by pressing at the pocket site on the implantable pulse generator, ipg header where the adaptor cables exit the ipg.The ipg pocket site was opened, the physician was then unable to trigger the shocks.Nevertheless, the physician decided to replace both lead adaptors with new ones.The patient was doing well post-operatively.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: brand name: precision, upn: m365sc9208150, model: sc-9208-15, serial: (b)(6), batch: (b)(6).The returned boston scientific scs lead adaptors were analyzed, passed all tests performed, and exhibited normal device characteristics.The labeling review states that boston scientific scs lead adaptors are intended to connect to non-boston scientific scs leads.In this case, the dbs patient had boston scientific spinal cord stimulation, scs lead adaptors connected to non-boston scientific deep brain stimulation leads which is contraindicated.Therefore, with the available information, engineers have determined that the lead adaptors were used in an off-label, unapproved, contraindicated manner that likely resulted in the reported events of inadequate stimulation and electrical shocks throughout the body.

• 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 15341755
• Report Number: 3006630150-2022-04455
• Device Sequence Number: 5230978
• Product Code: LGW
• UDI-Device Identifier: 08714729893271
• UDI-Public: 08714729893271
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 11/29/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/28/2020
• Device Model Number: SC-9208-15
• Device Catalogue Number: SC-9208-15
• Device Lot Number: 7030967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2018
• 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