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

Model Number SC-2317-50

Device Problems Fracture (1260); Difficult to Insert (1316); Failure to Disconnect (2541)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 10/23/2018

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model: sc-3138-55; serial/lot: (b)(4); description: lead extension kit, 55 cm.

Event Description

A report was received that during the permanent implant procedure, the physician tried to connect the lead to a lead extension.The lead was inserted about halfway into the lead extension when the physician tried to remove the lead from the lead extension the lead broke.The physician decided that the lead would remain implanted as the patient was receiving good therapy.Device analysis on the returned lead revealed that only six of the contacts were returned.Extensive tensile force was exerted on the proximal end of the lead and resulted in the separation contacts 1-6 from the rest of the lead.Returned lead extension, serial number (b)(4), was analyzed and no anomalies were found.A review of the manufacturing documentation for the lead extension, serial number (b)(4), revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.

Manufacturer Narrative

Additional suspect medical device components involved in the event: model: sc-3138-55 serial/lot: (b)(4) description: lead extension kit, 55 cm.

Event Description

A report was received that during the permanent implant procedure, the physician tried to connect the lead to a lead extension.The lead was inserted about halfway into the lead extension when the physician tried to remove the lead from the lead extension the lead broke.The physician decided that the lead would remain implanted as the patient was receiving good therapy.Device analysis on the returned lead revealed that only six of the contacts were returned.Extensive tensile force was exerted on the proximal end of the lead and resulted in the separation contacts 1-6 from the rest of the lead.Returned lead extension, serial number (b)(4), was analyzed and no anomalies were found.A review of the manufacturing documentation for the lead extension, serial number (b)(4), revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.

• Brand Name: INFINION CX
• 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: 8350200
• MDR Text Key: 136490120
• Report Number: 3006630150-2019-00648
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729861614
• UDI-Public: 08714729861614
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/03/2020
• Device Model Number: SC-2317-50
• Device Catalogue Number: SC-2317-50
• Device Lot Number: 5011781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Date Manufacturer Received: 02/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other