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

Model Number SC-2218-50

Device Problems High impedance (1291); Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/05/2021

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: upn: m365sc2218700, model: sc-2218-70, serial: (b)(4), batch: 7071970.

Event Description

It was reported that the patient was experiencing loss of paresthesia of pain areas.High impedances were noted on both leads.The patient underwent a revision procedure in which the physician implanted one new lead, and upgraded the implantable pulse generator (ipg).The two leads that displayed high impedances remain implanted.The explanted ipg was discarded.No additional adverse patient effects were reported.

Manufacturer Narrative

Correction to initial mdr in field d6a.Additional suspect medical device components involved in the event- upn: m365sc2218700, model: sc-2218-70, serial: (b)(6), batch: (b)(6).

Event Description

It was reported that the patient was experiencing loss of paresthesia of pain areas.High impedances were noted on both leads.The patient underwent a revision procedure in which the physician implanted one new lead, and upgraded the implantable pulse generator (ipg).The two leads that displayed high impedances remain implanted.The explanted ipg was discarded.No additional adverse patient effects were reported.

• Brand Name: LINEAR ST
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 12388759
• MDR Text Key: 268878787
• Report Number: 3006630150-2021-04863
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767725
• UDI-Public: 08714729767725
• Combination Product (y/n): N
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/27/2018
• Device Model Number: SC-2218-50
• Device Catalogue Number: SC-2218-50
• Device Lot Number: 19518064
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 08/30/2021
• Supplement Dates Manufacturer Received: 09/21/2021
• Supplement Dates FDA Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention