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

Model Number SC-1200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Paralysis (1997); No Code Available (3191)

Event Date 12/13/2018

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: (b)(4), model: sc-2218-70, serial: (b)(4), batch: 21636188.Product family: scs-linear leads, upn: (b)(4), model: sc-2218-70, serial: (b)(4), batch: 5091334.

Event Description

It was reported that the patient was experiencing discomfort at the anchor and implantable pulse generator (ipg) sites.The patient reported that the leads caused muscle spasms and severe pain on the left side between the spine and shoulder blade; the leads started to protrude from the spine which caused severe pain.The physician revised the patient in 2019 but the muscles spasms and pain increased so the physician prescribed pain medication and muscle relaxers.The patient reported receiving a second opinion from a surgeon who indicated that patient had a pinched nerve.The patient underwent additional surgery to repair the neck and a spinal cord stimulator explant procedure.The patient also reports being declared disabled and is still in severe pain from initial placement of stimulator.No further information has been obtained despite good faith efforts.

• 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: 10607828
• MDR Text Key: 209212049
• Report Number: 3006630150-2020-04541
• 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: consumer
• Type of Report: Initial
• Report Date: 09/30/2020

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/12/2020
• Device Model Number: SC-1200
• Device Catalogue Number: SC-1200
• Device Lot Number: 358729
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2018
• 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: 53 YR