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); Defective Device (2588); Battery Problem (2885)

Patient Problem No Code Available (3191)

Event Date 05/12/2020

Event Type  Injury  

Manufacturer Narrative

Approximated based on the date the manufacturer became aware of the event.

Event Description

It was reported that the patients was having inadequate stimulation due to non-functional ipg.The patient underwent an ipg explant procedure.

Manufacturer Narrative

Sc - 1140, sn (b)(6).Device evaluation indicated that the device passed all tests performed.

Event Description

It was reported that the patients was having inadequate stimulation due to non-functional ipg.The patient underwent a novi ipg explant procedure.

• 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
• MDR Report Key: 10315283
• MDR Text Key: 200413761
• Report Number: 3006630150-2020-03056
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729897835
• UDI-Public: 08714729897835
• 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: 09/08/2020

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: 12/20/2019
• Device Model Number: SC-1140
• Device Catalogue Number: SC-1140
• Device Lot Number: 200493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 08/20/2020
• Supplement Dates FDA Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 61