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

Model Number SC-1132

Device Problems High impedance (1291); Unexpected Therapeutic Results (1631); Charging Problem (2892); Wireless Communication Problem (3283)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Block b3: exact date unknown, event occurred approximately in 2020.Additional suspect medical device component involved in the event: product family: scs-extension, upn: m365sc3138250, model: sc-3138-25, serial: (b)(6), batch: 16776077/17139693.

Event Description

It was reported that patients spinal cord stimulator (scs) was damaged during an mri scan resulting in difficulty in charging of the ipg.The patient was also experiencing high impedance, inadequate pain coverage and loss of therapy due to the ipgs inability to connect with the remote.Database analysis confirmed that ipg appeared to be working as expected.The patient underwent a revision procedure where in the old ipg and leads were replaced.The patient was doing well postoperatively.

Event Description

It was reported that patients spinal cord stimulator (scs) was damaged during an mri scan resulting in difficulty in charging of the ipg.The patient was also experiencing high impedance, inadequate pain coverage and loss of therapy due to the ipgs inability to connect with the remote.Database analysis confirmed that ipg appeared to be working as expected.The patient underwent a revision procedure where in the old ipg and leads were replaced.The patient was doing well postoperatively.Additional information was received that the explanted devices were not returned as they were disposed by the medical facility.

• Brand Name: PRECISION SPECTRA
• 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 19008575
• MDR Text Key: 338981675
• Report Number: 3006630150-2024-01939
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729821526
• UDI-Public: 08714729821526
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2017
• Device Model Number: SC-1132
• Device Catalogue Number: SC-1132
• Device Lot Number: 18361913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2015
• 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: 50 YR
• Patient Sex: Male