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

Model Number	SC-2158-50
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Approximated based on the date x-ray test was taken.Additional suspect medical device component involved in the event: product family: scs-linear leads, upn: m365sc2158500, model: sc-2158-50, serial: (b)(4), batch: 13465796.
Event or Problem Description
It was reported that the patient experienced inadequate stimulation due to lead migration as confirmed via x-ray.The patient underwent a revision procedure wherein the leads were replaced.The patient was doing well postoperatively.The explanted leads were discarded.

• 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: 12246315
• Report Number: 3006630150-2021-04206
• Device Sequence Number: 4440697
• Product Code: LGW
• UDI-Device Identifier: 08714729767695
• UDI-Public: 08714729767695
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2021

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: 04/30/2012
• Device Model Number: SC-2158-50
• Device Catalogue Number: SC-2158-50
• Device Lot Number: 299884
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 07/29/2021
• 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
• Patient Age: 59 YR
• Patient Weight: 136