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

Model Number SC-1200

Device Problems Fracture (1260); High impedance (1291); Unexpected Therapeutic Results (1631); Wireless Communication Problem (3283); Intermittent Energy Output (4025)

Patient Problems Burning Sensation (2146); Inadequate Pain Relief (2388)

Event Date 04/26/2021

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: scs-linear leads.Upn: m365sc2317700.Model: sc-2317-70.Serial: (b)(4).Batch: 7072232.

Event Description

It was reported that approximately six months after the permanent implant procedure the implantable pulse generator (ipg) started to switch off on its own.In addition, the patient was experiencing a partial loss of therapy.An impedance check revealed multiple contacts of the lead displayed high impedances.Reprogramming was attempted, however the ipg continued switching off.The patient reported there were no situations that would have exposed the patient to large magnetic fields etc.The patient underwent a revision procedure in which the physician replaced the entire system.The explanted ipg and lead will be returned.The patient is doing well post operatively.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: scs-linear leads.Upn: m365sc2317700.Model: sc-2317-70.Serial: (b)(6).Batch: 7072232.

Event Description

It was reported that approximately six months after the permanent implant procedure the implantable pulse generator (ipg) started to switch off on its own.In addition, the patient was experiencing a partial loss of therapy.An impedance check revealed multiple contacts of the lead displayed high impedances.Reprogramming was attempted, however the ipg continued switching off.The patient reported there were no situations that would have exposed the patient to large magnetic fields etc.The patient underwent a revision procedure in which the physician replaced the entire system.The explanted ipg and lead will be returned.The patient is doing well post operatively.

Manufacturer Narrative

Sc-1200, serial (b)(6): engineers inspected and analyzed this device upon receipt.The implantable pulse generator (ipg) system reset count was 3, that suggested no stimulation interruption due to ipg malfunction prior to the product return.Monitored stimulation on an oscilloscope found the outputs were consistent and correct on all electrodes.Current leakage tests and residual gas analysis verified no loss of electric current into the surrounding tissue.The complaint of the ipg switching off was not confirmed.It passed the functional test, and an electrical test revealed normal device characteristics.Sc-2317-70, serial (b)(6): the complaint of high impedances on one of the leads was confirmed.Visual and x-ray inspections of the returned lead confirmed seven cables were fractured at the clik site, about 15.5 centimeters from the distal end that resulted in the source of high impedances.

Event Description

It was reported that approximately six months after the permanent implant procedure the implantable pulse generator (ipg) started to switch off on its own.In addition, the patient was experiencing a partial loss of therapy.An impedance check revealed multiple contacts of the lead displayed high impedances.Reprogramming was attempted, however the ipg continued switching off.The patient reported there were no situations that would have exposed the patient to large magnetic fields etc.The patient underwent a revision procedure in which the physician replaced the entire system.The explanted ipg and lead will be returned.The patient is doing well post operatively.

Manufacturer Narrative

Sc-1200, serial (b)(6): engineers inspected and analyzed this device upon receipt.The implantable pulse generator (ipg) system reset count was 3, that suggested no stimulation interruption due to ipg malfunction prior to the product return.Monitored stimulation on an oscilloscope found the outputs were consistent and correct on all electrodes.Current leakage tests and residual gas analysis verified no loss of electric current into the surrounding tissue.The complaint of the ipg switching off was not confirmed.It passed the functional test, and an electrical test revealed normal device characteristics.Sc-2317-70, serial (b)(6): the complaint of high impedances on one of the leads was confirmed.Visual and x-ray inspections of the returned lead confirmed seven cables were fractured at the clik site, about 15.5 centimeters from the distal end that resulted in the source of high impedances.

Event Description

It was reported that approximately six months after the permanent implant procedure the implantable pulse generator (ipg) started to switch off on its own.In addition, the patient was experiencing a partial loss of therapy.An impedance check revealed multiple contacts of the lead displayed high impedances.Reprogramming was attempted, however the ipg continued switching off.The patient reported there were no situations that would have exposed the patient to large magnetic fields etc.The patient underwent a revision procedure in which the physician replaced the entire system.The explanted ipg and lead will be returned.The patient is doing well post operatively.Additional information was received that the patient was also experiencing a warming sensation at the ipg site.

Manufacturer Narrative

Sc-1200, (b)(6).Engineers inspected and analyzed this device upon receipt.The ipg system reset count was 3, that suggested no stimulation interruption due to ipg malfunction prior to the product return.Monitored stimulation on an oscilloscope found the outputs were consistent and correct on all electrodes.Current leakage tests and residual gas analysis verified no loss of electric current into the surrounding tissue.The highest temperature during charging cycles in the patients body registered within the acceptable range it passed the functional test, and an electrical test revealed normal device characteristics.Sc-2317-70, (b)(6).The complaint of high impedances on one of the leads was confirmed.Visual and x-ray inspections of the returned lead confirmed seven cables were fractured at the clik site, about 15.5 centimeters from the distal end that resulted in the source of high impedances.When excessive mechanical-tensile force was exerted onto the lead, the lead became kinked after exiting the clik anchor resulting in the cable fractures.

Event Description

It was reported that approximately six months after the permanent implant procedure the implantable pulse generator (ipg) started to switch off on its own.In addition, the patient was experiencing a partial loss of therapy.An impedance check revealed multiple contacts of the lead displayed high impedances.Reprogramming was attempted, however the ipg continued switching off.The patient reported there were no situations that would have exposed the patient to large magnetic fields etc.The patient underwent a revision procedure in which the physician replaced the entire system.The explanted ipg and lead will be returned.The patient is doing well post operatively.Additional information was received that the patient was also experiencing a warming sensation at the ipg site.

• 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
• 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: 11980132
• MDR Text Key: 256723707
• Report Number: 3006630150-2021-02843
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729905943
• UDI-Public: 08714729905943
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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,Followup,Followup,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/06/2022
• Device Model Number: SC-1200
• Device Catalogue Number: SC-1200
• Device Lot Number: 370617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2020
• 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