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); Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 01/31/2020

Event Type  malfunction  

Event Description

A report was received that during the trial procedure, the lead was difficult to position and got stuck into the epidural space and was hitting resistance.The physician kept trying to remove it until the lead broke after the fifth contact and completely separated from the rest of the lead.It was also reported that the remaining fragment of the lead was removed.The patient was doing well post operatively.

Manufacturer Narrative

Device evaluation indicated that the complaint damage of the lead has been confirmed.Visual inspection revealed that the top five electrodes are separated from the distal end.Electrodes 1-5 were not returned.The cables are exposed at the damaged portion of the lead.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 45 degrees.An angle of more than 45 degrees increases the risk of lead damage.Dfu states that use only an insertion needle provided by boston scientific.Other needles may damage the lead.The number 14 on the needle hub corresponds to the orientation of the bevel, which must face up.Turning the bevel ventral down may result in lead damage.An angle of more than 45 degrees increases the risk of lead damage.The probable cause selected is unintended use error caused or contributed to event.

Event Description

A report was received that during the trial procedure, the lead was difficult to position and got stuck into the epidural space and was hitting resistance.The physician kept trying to remove it until the lead broke after the fifth contact and completely separated from the rest of the lead.It was also reported that the remaining fragment of the lead was removed.The patient was doing well post operatively.

• 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: 9731281
• MDR Text Key: 180130101
• Report Number: 3006630150-2020-00687
• 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: 03/31/2020

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: 10/22/2021
• Device Model Number: SC-2316-50E
• Device Catalogue Number: SC-2316-50E
• Device Lot Number: 7071923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Initial Date Manufacturer Received: 01/31/2020
• Initial Date FDA Received: 02/20/2020
• Supplement Dates Manufacturer Received: 03/11/2020
• Supplement Dates FDA Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR