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

Model Number SC-1140

Device Problems Premature Discharge of Battery (1057); Unexpected Therapeutic Results (1631); Battery Problem (2885)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

Exact date unknown, event occurred approximately 12 months after implant.

Event Description

It was reported the patient received the end of service message for the implantable pulse generator (ipg) and experienced a loss of stimulation after 12 months of use.The patient underwent a revision procedure where the ipg was replaced, and did well post-operatively.The energy use index revealed high energy usage that was inline with the 12 month lifespan; however, the physician will return the ipg for analysis to exclude any potential device malfunction as a contributing factor to the reported event.

Event Description

It was reported the patient received the end of service message for the implantable pulse generator (ipg) and experienced a loss of stimulation after 12 months of use.The patient underwent a revision procedure where the ipg was replaced, and did well post-operatively.The energy use index revealed high energy usage that was inline with the 12 month lifespan; however, the physician will return the ipg for analysis to exclude any potential device malfunction as a contributing factor to the reported event.

Manufacturer Narrative

Laboratory analysis of the returned implantable pulse generator (ipg) showed the device was in service for approximately 12 months, and the expected lifespan based on the eui was 8 months per directions for use.However, the patient data that was extracted from the ipg revealed a sudden battery drop which significantly shortened the device's longevity.Due to the fact that physical analysis of the ipg revealed no anomalies, a definitive root cause of the reported premature battery depletion could not be established.However, engineers have determined the proximal cause of the premature battery depletion was high voltage.High voltage is used to drive stimulation and maintain compliance voltage at the electrodes; but the cause of the high voltage could not be identified.Two potential hypotheses have been surmised regarding the cause of the high voltage: either the compliance voltage algorithm (cva) has an unknown failure mode that causes high voltage to be driven high for the required impedance load, or the impedance load was unexpectedly high and the cva correctly increased to enable the stimulation.Although, the rep reported no high impedance readings, engineers have assessed that both proximal causes are consistent with the available data.

• 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; cashel road; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12721699
• MDR Text Key: 279095860
• Report Number: 3006630150-2021-06081
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729897835
• UDI-Public: 08714729897835
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2022

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: 10/08/2021
• Device Model Number: SC-1140
• Device Catalogue Number: SC-1140
• Device Lot Number: 202327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 10/29/2021
• Supplement Dates Manufacturer Received: 12/20/2021
• Supplement Dates FDA Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2019
• 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