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)

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

Event Date 03/29/2021

Event Type  malfunction  

Event Description

It was reported that following a trial procedure, the physician was pulling out the lead and felt resistance and the lead fractured.All device components were removed in the patients body two days after the lead pull.

Event Description

It was reported that following a trial procedure, the physician was pulling out the lead and felt resistance and the lead fractured.All device components were removed in the patients body two days after the lead pull.

Manufacturer Narrative

Sc-2316-50e (sn: (b)(6).The returned lead was analyzed and it was revealed that the visual inspection found the distal end was fractured.Visual inspection of the fractured cables revealed fraying of the breaks, lack of necking and discoloration associated with welding, and the proximity of the break points to the edge of the insulation indicate that the cables didn't break at or near the welds.With all the available information, boston scientific concludes that the allegation of lead damage was confirmed.It appears that resistance was felt during the lead pull and lead was subjected to excessive tensile load causing damage to the distal array.

• 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: 11678252
• MDR Text Key: 245793861
• Report Number: 3006630150-2021-01605
• 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: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/08/2023
• Device Model Number: SC-2316-50E
• Device Catalogue Number: SC-2316-50E
• Device Lot Number: 7118506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Date Manufacturer Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR