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

Model Number SC-1140

Device Problems Unexpected Therapeutic Results (1631); Battery Problem (2885)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/12/2022

Event Type  Injury  

Manufacturer Narrative

Date of event: approximated based on the date the manufacturer became aware of the event.

Event Description

It was reported that the patient was experiencing inadequate stimulation.It was also noted that the ipg is at its end of life.The patient underwent an ipg replacement procedure and was doing well postoperatively.

Event Description

It was reported that the patient was experiencing inadequate stimulation.It was also noted that the ipg is at its end of life.The patient underwent an ipg replacement procedure and was doing well postoperatively.Additional information was received that the explanted ipg will not be returned as it was discarded by the medical facility.

• Brand Name: PRECISION NOVI
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 15153837
• MDR Text Key: 297131374
• Report Number: 3006630150-2022-03801
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729897835
• UDI-Public: 08714729897835
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/29/2022

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: 08/25/2019
• Device Model Number: SC-1140
• Device Catalogue Number: SC-1140
• Device Lot Number: 21049670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 08/02/2022
• Supplement Dates Manufacturer Received: 08/04/2022
• Supplement Dates FDA Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female