MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION LINEAR 3-4; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-2352-50

Device Problems Fracture (1260); High impedance (1291); Unexpected Therapeutic Results (1631)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/04/2021

Event Type  malfunction  

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), batch: 7072748.

Event Description

It was reported that the patient was experiencing loss of therapy.High impedances were noted on one of the two leads.An x-ray revealed that one of the leads was fractured.The patient had a particularly violent sneeze that may have caused it.It is not known which of the two leads had the high impedances and fracture.It was noted that during the permanent implant procedure, the leads were sutured, not anchored.Reprogramming will be performed to avoid the damaged lead.The leads remain implanted and there is no intention to surgically revise.

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: (b)(6).

Event Description

It was reported that the patient was experiencing loss of therapy.High impedances were noted on one of the two leads.An x-ray revealed that one of the leads was fractured.The patient had a particularly violent sneeze that may have caused it.It is not known which of the two leads had the high impedances and fracture.It was noted that during the permanent implant procedure, the leads were sutured, not anchored.Reprogramming will be performed to avoid the damaged lead.The leads remain implanted and there is no intention to surgically revise.

• Brand Name: LINEAR 3-4
• 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12373609
• MDR Text Key: 268340311
• Report Number: 3006630150-2021-04776
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729789550
• UDI-Public: 08714729789550
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/16/2023
• Device Model Number: SC-2352-50
• Device Catalogue Number: SC-2352-50
• Device Lot Number: 7072796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 11/08/2021
• Supplement Dates FDA Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2021
• 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): Other