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

Model Number SC-1132

Device Problems Unexpected Therapeutic Results (1631); Use of Device Problem (1670)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/06/2022

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2352500, model: sc-2352-50, serial: (b)(4) and (b)(4), batch: 19512161 and 19397779.Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2218500, model: sc-2218-50, serial: (b)(4) and (b)(4), batch: 19709364 and 18940822.

Event Description

It was reported that the patient experienced loss of therapy, the patient underwent a spinal cord stimulator (scs) full system replacement procedure.The patient had previously undergone an unrelated back surgery procedure in which monopolar electrocautery may have been used and may have damaged the implantable pulse generator (ipg).The patient is doing well post-operatively.

Event Description

It was reported that the patient experienced loss of therapy, the patient underwent a spinal cord stimulator (scs) full system replacement procedure.The patient had previously undergone an unrelated back surgery procedure in which monopolar electrocautery may have been used and may have damaged the implantable pulse generator (ipg).The patient is doing well post operatively.Monopolar electrocautery is a known source of high voltage transient signal and current company labeling warns against the use of monopolar electrocautery.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2352500, model: sc-2352-50, serial: (b)(6), batch: 19512161 and 19397779.Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2218500, model: sc-2218-50, serial: (b)(6), batch: 19709364 and 18940822.The returned devices were analyzed, and passed all tests performed, and exhibited normal device characteristics.Only the proximal ends of the leads were returned, however no anomalies were identified on the portions returned.A labeling review was performed on all of the devices' instructions for use, ifu.There was no evidence that the devices were used in a manner inconsistent with the labeled indications.Based on all available information, engineers are not able to confirm the root cause of the event.The devices were returned and analyzed, as such physical analysis was conducted, record review revealed no additional information related to the complaint.Therefore, this investigation is not able to determine a probable root cause for the complaint and the conclusion is no problem detected.

• Brand Name: PRECISION SPECTRA
• Type of Device: 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: 15154154
• MDR Text Key: 297140678
• Report Number: 3006630150-2022-03802
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729821526
• UDI-Public: 08714729821526
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/19/2018
• Device Model Number: SC-1132
• Device Catalogue Number: SC-1132
• Device Lot Number: 19723249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention