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

Model Number	SC-2158-50
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: approximated based on the reported event.Implant date: (b)(6) 2011, exact date unknown.Explant date: 2011, exact date unknown.
Event or Problem Description
It was reported that during the second stage implant procedure, one of the two previously implanted leads was explanted and replaced.It is unclear which of the two leads was explanted and which remained implanted.
Additional Manufacturer Narrative
Block b3: approximated based on the reported event.Block d6a: implant date: (b)(6) 2011, exact date unknown.Black d6b: explant date: 2011, exact date unknown.Correction to field h10: additional suspect medical device component involved in the event: product family: scs-linear leads.Upn: m365sc2158500.Model: sc-2158-50.Serial: (b)(6).Batch: 14178435.
Event or Problem Description
It was reported that during the second stage implant procedure, one of the two previously implanted leads was explanted and replaced.It is unclear which of the two leads was explanted and which remained implanted.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
• MDR Report Key: 12451557
• Report Number: 3006630150-2021-05076
• Device Sequence Number: 3936080
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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?: No
• 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: 14147787
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention