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

Model Number SC-2317-70

Device Problems High impedance (1291); Unexpected Therapeutic Results (1631)

Patient Problems Wound Dehiscence (1154); Erosion (1750); Staphylococcus Aureus (2058); Impaired Healing (2378); No Code Available (3191)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: scs-ipg-r upn: (b)(4), model: sc-1160, serial: (b)(4), batch: 362743.

Event Description

It was reported that the patient experienced protrusion at the lead site.The patient had a large scar due to prior spine surgeries and the physician believes the reported protrusion is due to less perfusion of the scar tissue.This issue coupled with the fact that stimulation was no longer adequately covering the patient's pain and reprogramming did not result in full coverage, it was decided that the patient would undergo a revision or explant procedure at a future date.No further information has been reported.

Event Description

It was reported that the patient experienced protrusion at the lead site.The patient had a large scar due to prior spine surgeries and the physician believes the reported protrusion is due to less perfusion of the scar tissue.This issue coupled with the fact that stimulation was no longer adequately covering the patients pain and reprogramming did not result in full coverage, it was decided that the patient would undergo a revision or explant procedure at a future date.No further information has been reported.Additional information received that the patient underwent an explant procedure.

Event Description

It was reported that the patient experienced protrusion at the lead site.The patient had a large scar due to prior spine surgeries and the physician believes the reported protrusion is due to less perfusion of the scar tissue.This issue coupled with the fact that stimulation was no longer adequately covering the patients pain and reprogramming did not result in full coverage, it was decided that the patient would undergo a revision or explant procedure at a future date.No further information has been reported.Additional information received that the patient underwent an explant procedure.Additional information received indicates the patient had redness at the lead site and tested positive for staphylococcus epidermis.Patient was placed on moxifloxacin and cephaclor and underwent an explant procedure to remove the entire scs system.Physician assessed that a melanoma found near the lead site caused the reported issues.Patient is doing fine post-explant procedure.

Manufacturer Narrative

Visual and x-ray inspections of the lead serial number (b)(6) revealed fractured cables near the proximal array retention sleeve.It appears that the lead body was exposed to excessive mechanical/tensile force causing it to be kinked and fractured after it exits the ipg port.Additionally, the lead was cleanly cut, which is a result of a typical explant procedure, and it is not considered a failure.Visual inspection of the ipg serial number (b)(6) revealed no anomalies.Ipg was damage when being returned for analysis; therefore, a residual gas analysis could not be performed.The complaint of high impedance was confirmed through product analysis.The probable cause was traced to component failure.The complaint of protrusion and infection was assessed by the physician as being related to a melanoma found near the lead site; therefore the probable cause was adverse event related to patient condition.

Event Description

It was reported that the patient experienced protrusion at the lead site.The patient had a large scar due to prior spine surgeries and the physician believes the reported protrusion is due to less perfusion of the scar tissue.This issue coupled with the fact that stimulation was no longer adequately covering the patients pain and reprogramming did not result in full coverage, it was decided that the patient would undergo a revision or explant procedure at a future date.No further information has been reported.Additional information received that the patient underwent an explant procedure.Additional information received indicates the patient had redness at the lead site and tested positive for staphylococcus epidermis.Patient was placed on moxifloxacin and cephaclor and underwent an explant procedure to remove the entire scs system.Physician assessed that a melanoma found near the lead site caused the reported issues.Patient is doing fine post-explant procedure.

• 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: 10247769
• MDR Text Key: 198169177
• Report Number: 3006630150-2020-02820
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729861638
• UDI-Public: 08714729861638
• 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,Followup,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/09/2021
• Device Model Number: SC-2317-70
• Device Catalogue Number: SC-2317-70
• Device Lot Number: 7070287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Date Manufacturer Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention