MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION INFINION 16; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-2316-50E

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 05/15/2020

Event Type  malfunction  

Manufacturer Narrative

The device was disposed of and will not be returned for evaluation; therefore, a technical product analysis of the device could not be completed.

Event Description

It was reported that during a lead removal, the physician had fractured the lead while pulling.It was noted that some contacts were left in patients subcutaneous tissue.No further course of action will be taken at this time.

Event Description

It was reported that during a trial lead removal, the physician had fractured the lead while pulling.It was noted that some contacts were left in patients subcutaneous tissue.No further course of action will be taken at this time.Additional information was received that the patients percutaneous lead was removed from the patients body during the permanent implant procedure.The patient was doing well postoperatively.The explanted trial lead was disposed.

• Brand Name: INFINION 16
• 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: 10121271
• MDR Text Key: 194100498
• Report Number: 3006630150-2020-02345
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729797807
• UDI-Public: 08714729797807
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

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: 02/20/2022
• Device Model Number: SC-2316-50E
• Device Catalogue Number: SC-2316-50E
• Device Lot Number: 7088563
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 06/04/2020
• Supplement Dates Manufacturer Received: 06/22/2020
• Supplement Dates FDA Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR