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

Model Number SC-1200

Device Problems Charging Problem (2892); Power Problem (3010); Intermittent Energy Output (4025)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2021

Event Type  Injury  

Manufacturer Narrative

Implant date - approximate, implant date (b)(6) 2020.

Event Description

It was reported that the patient experienced difficulty charging the ipg, and intermittent stimulation.The issues persisted despite replacing the charging kit.The patient underwent a revision procedure to replace the ipg and was doing well post-operatively with stimulation working as expected.

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: scs-linear leads, upn: m365sc2317700, model: sc-2317-70, serial: (b)(6), batch/lot: (b)(6).Device technical analysis: a review of the manufacturing records associated with the ipg model sc-1200 serial number (b)(6) indicated that it was successfully processed according to requirements.The dhr did not identify any manufacturing process-related non-conformances, scrap, or rework performed during production that could have caused or contributed to this event.The dhr review ensures each device meets required specifications and associated testing prior to release for distribution/sale.Investigation conclusion: based on all available information, engineers concluded that the patients difficulty charging could not be confirmed as the ipg was able to be charged 3.985 volts in one cycle and a review of the data found no anomalies.The investigation of the associated lead concluded that the lead became bent after exiting the clik x anchor which exposed the bent location to excessive mechanical force or movement that caused the lead cables to fracture.Therefore the engineers concluded that the intermittent stimulation was dues to the lead fracture and no problem was detected with the ipg.

Event Description

It was reported that the patient experienced difficulty charging the ipg, and intermittent stimulation.The issues persisted despite replacing the charging kit.The patient underwent a revision procedure to replace the ipg and was doing well post-operatively with stimulation working as excepted.

• 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: 11500151
• MDR Text Key: 240303144
• Report Number: 3006630150-2021-01033
• 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
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/19/2021
• Device Model Number: SC-1200
• Device Catalogue Number: SC-1200
• Device Lot Number: 365416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2021
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention