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

Model Number SC-1132

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/11/2021

Event Type  Injury  

Event Description

It was reported that the patient experienced inadequate stimulation.The patient underwent an explant procedure to remove the entire system.The implantable pulse generator (ipg) and two leads were explanted.

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: scs-linear leads, upn: m365sc2317700, model: sc-2317-70, serial: (b)(4), batch: 21086447.Product family: scs-linear leads, upn: m365sc2317700, model: sc-2317-70, serial: (b)(4), batch: 21086447.

Manufacturer Narrative

With all available information, boston scientific concludes the reported event of inadequate stimulation was unable to be confirmed as the devices passed all tests performed.Laboratory analysis of the returned devices did not identify any product performance- related issues.Device technical analysis: the returned ipg sc-1132 serial number (b)(6) passed the functional test and revealed no anomalies.The leads sc-2317-70 serial number (b)(6) were returned and analyzed.The leads were cleanly cut, and 8 cm of the proximal end portions were returned.No anomalies were identified on the leads aside from the clean-cut.The damage to the leads is a result of a typical explant procedure.

Event Description

It was reported that the patient experienced inadequate stimulation.The patient underwent an explant procedure to remove the entire system.The implantable pulse generator (ipg) and two leads were explanted.

Event Description

It was reported that the patient experienced inadequate stimulation.The patient underwent an explant procedure to remove the entire system.The implantable pulse generator (ipg) and two leads were explanted.

• 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; cashel road; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12930314
• MDR Text Key: 282095469
• Report Number: 3006630150-2021-06933
• 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,Followup
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/25/2019
• Device Model Number: SC-1132
• Device Catalogue Number: SC-1132
• Device Lot Number: 203196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2017
• 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