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

Model Number SC-1110-02

Device Problems Unexpected Therapeutic Results (1631); Charging Problem (2892)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/22/2022

Event Type  Injury  

Event Description

It was reported that the patient was no longer able to charge the implantable pulse generator (ipg), and the device was not helping her pain any longer.The patient underwent an ipg replacement procedure.During the procedure, one of the leads could not get connected to the ipg as the lead was corroded.The patient had good coverage on one side post-operatively, however will most likely undergo a revision procedure at a later date due to the one-sided coverage.The explanted ipg will not be returned due to hospital policy.

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: scs-linear leads: upn: m365sc2218700.Model: sc-2218-70.Serial: (b)(4).Batch: 257240.

Event Description

It was reported that the patient was no longer able to charge the implantable pulse generator (ipg), and the device was not helping her pain any longer.The patient underwent an ipg replacement procedure.During the procedure, one of the leads could not get connected to the ipg as the lead was corroded.The patient had good coverage on one side post-operatively, however will most likely undergo a revision procedure at a later date due to the one-sided coverage.The explanted ipg will not be returned due to hospital policy.Additional information was received that there will be no further course of action.

• Brand Name: PRECISION
• 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: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 15587619
• MDR Text Key: 301573132
• Report Number: 3006630150-2022-05479
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767688
• UDI-Public: 08714729767688
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2014
• Device Model Number: SC-1110-02
• Device Catalogue Number: SC-1110-02
• Device Lot Number: 15183814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2012
• 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
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 100 KG