MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION MONTAGE MRI; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-1200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Impaired Healing (2378)

Event Date 05/05/2021

Event Type  Injury  

Event Description

It was reported that the patient had a small opening at the corner of her incision site that was oozing clear fluid.A dissolvable suture was visible through the small opening.There was another very small opening present at the mid-pocket incision.The patient underwent a pocket revision procedure to reposition the implantable pulse generator (ipg).The patient had lost (b)(6) since the original implant procedure and the ipg was titled in the pocket.It was possible that an ipg suture was broken, and the ipg was re-sutured in place after being placed in an antimicrobial pouch.While the incision was open, wound cultures were performed and a sample was sent to the laboratory.The patient was previously placed on keflex, a 5 day course of antibiotics.No cultures were drawn previously.

Event Description

It was reported that the patient had a small opening at the corner of her incision site that was oozing clear fluid.A dissolvable suture was visible through the small opening.There was another very small opening present at the mid-pocket incision.The patient underwent a pocket revision procedure to reposition the implantable pulse generator (ipg).The patient had lost 20lbs since the original implant procedure and the ipg was titled in the pocket.It was possible that an ipg suture was broken, and the ipg was re-sutured in place after being placed in an antimicrobial pouch.While the incision was open, wound cultures were performed and a sample was sent to the laboratory.The patient was previously placed on keflex, a 5 day course of antibiotics.No cultures were drawn previously.Additional information was received that the patient will be seen in the clinic for an incision check.The ipg pocket cultures came back negative.The patient was never diagnosed for an infection.

Event Description

It was reported that the patient had a small opening at the corner of her incision site that was oozing clear fluid.A dissolvable suture was visible through the small opening.There was another very small opening present at the mid-pocket incision.The patient underwent a pocket revision procedure to reposition the implantable pulse generator (ipg).The patient had lost 20lbs since the original implant procedure and the ipg was titled in the pocket.It was possible that an ipg suture was broken, and the ipg was re-sutured in place after being placed in an antimicrobial pouch.While the incision was open, wound cultures were performed and a sample was sent to the laboratory.The patient was previously placed on keflex, a 5 day course of antibiotics.No cultures were drawn previously.Additional information was received that the clinic nurses report that the incision is now well healed.

• Brand Name: PRECISION MONTAGE MRI
• 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: 11904697
• MDR Text Key: 254281880
• Report Number: 3006630150-2021-02487
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729905943
• UDI-Public: 08714729905943
• 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
• Report Date: 08/11/2021

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/21/2022
• Device Model Number: SC-1200
• Device Catalogue Number: SC-1200
• Device Lot Number: 371080
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/05/2021
• Initial Date FDA Received: 05/28/2021
• Supplement Dates Manufacturer Received: 05/28/2021; 07/16/2021
• Supplement Dates FDA Received: 06/25/2021; 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention