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); Difficult to Remove (1528); Use of Device Problem (1670); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2021

Event Type  Injury  

Event Description

It was reported that during a trial procedure the physician was having difficulty advancing the lead to the epidural space and removing the lead from the needle.It appeared that the edge of the third contact was engaged with the bevel on the tip of the needle which resulted to a fractured lead.The trial procedure was aborted and the patient was doing well postoperatively.

Manufacturer Narrative

Sc-2316-50e sn: (b)(6).The returned lead was analyzed and revealed that the distal end was bent between contacts which exposed the cables at the damaged portion.With all the available information, boston scientific concludes the reported event was confirmed.This kind of anomaly is consistent with the damages done to a lead when the orientation of the insertion needles bevel is facing down or the angle of the insertion needle is greater than forty five degree.The probable cause is due to unintended use error which caused or contributed to event.

Event Description

It was reported that during a trial procedure the physician was having difficulty advancing the lead to the epidural space and removing the lead from the needle.It appeared that the edge of the third contact was engaged with the bevel on the tip of the needle which resulted to a fractured lead.The trial procedure was aborted and the patient was doing well postoperatively.

• 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
• 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: 12686676
• MDR Text Key: 278078296
• Report Number: 3006630150-2021-05959
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729797807
• UDI-Public: 08714729797807
• 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: 11/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/24/2023
• Device Model Number: SC-2316-50E
• Device Catalogue Number: SC-2316-50E
• Device Lot Number: 7137435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2021
• 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): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male