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

Model Number	SC-3138-25
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a tangled lead extension causing discomfort.The patient underwent a revision wherein the extension was explanted and the ipg was repositioned.
Additional Manufacturer Narrative
Event date: exact date unknown, event occurred in (b)(6) 2021.Additional suspect medical device components involved in the event: product family: scs-extension, upn: (b)(4), model: sc-3138-35, serial: (b)(4), batch: (b)(4).Additional suspect medical device component involved in the event: product family: scs-extension, upn: (b)(4), model: sc-3138-55, serial: (b)(4), batch: (b)(4).Additional suspect medical device component involved in the event: product family: scs-ipg-r, upn: (b)(4), model: sc-1160, serial: (b)(4), batch: (b)(4).
Event or Problem Description
It was reported that the patient had a tangled lead extension causing discomfort.The patient underwent a revision wherein the extension was explanted and the ipg was repositioned.
Additional Manufacturer Narrative
Sc-1160 sn: (b)(6).The returned ipg was analyzed and the device was undetectable nor charged.The device was cut open.An internal electrical test revealed asic u2 damage.The complaint report indicates that a plasma blade was used during the lead revision.Exposure to high-voltage transients or high rf (radio frequency) energy can cause this type of damage.The probable cause selected is unintended use error caused or contributed to event.

• Brand Name: SPECTRA WAVEWRITER
• 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: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 13890604
• Report Number: 3006630150-2022-01216
• Device Sequence Number: 12322941
• Product Code: LGW
• UDI-Device Identifier: 08714729760542
• UDI-Public: 08714729760542
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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: 02/13/2022
• Device Model Number: SC-3138-25
• Device Catalogue Number: SC-3138-25
• Device Lot Number: 1114327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/02/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2017
• 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: 59 YR
• Patient Sex: Male