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); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

Approximated based on the date the manufacturer became aware of the event.

Event Description

It was reported that during an implant procedure, the physician had difficulty placing the lead and kept going anterior.The physician fractured the lead while pulling it out of the needle.Two contacts were dislodged and physician opted to leave it inside the patient but was eventually removed during the patients permanent implant procedure.The patient was doing well postoperatively.The fractured lead and dislodged contacts will be returned.

Manufacturer Narrative

Sc-2316-50e sn:(b)(6).The returned trial lead was analyzed and was reported that during an implant procedure, the physician had difficulty placing the lead and kept going anterior.The physician fractured the lead while pulling it out of the needle.Two contacts were dislodged, and physician opted to leave it inside the patient but was eventually removed during the patients permanent implant procedure.The patient was doing well postoperatively.The fractured lead and dislodged contacts will be returned.With all the available information, boston scientific concludes the lead damage has been confirmed.Visual inspection revealed that the lead was damaged and only electrodes # 1and 2 from the distal end were returned.The proximal portion of the lead was not returned.This kind of anomaly is consistent with the damages done to a lead during insertion when the orientation of the insertion needles bevel is facing down, or the angle of the insertion needle is greater than 45 degrees.Electrical test could not be performed due damaged lead.The probable cause selected is unintended use error caused or contributed to event.

Event Description

It was reported that during an implant procedure, the physician had difficulty placing the lead and kept going anterior.The physician fractured the lead while pulling it out of the needle.Two contacts were dislodged and physician opted to leave it inside the patient but was eventually removed during the patients permanent implant procedure.The patient was doing well postoperatively.The fractured lead and dislodged contacts will be returned.

• 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: 10340719
• MDR Text Key: 200872782
• Report Number: 3006630150-2020-03153
• 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: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/10/2022
• Device Model Number: SC-2316-50E
• Device Catalogue Number: SC-2316-50E
• Device Lot Number: 7087309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR