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

Model Number SC-1132

Device Problem Charging Problem (2892)

Patient Problems Chest Pain (1776); Inadequate Pain Relief (2388)

Event Date 03/13/2021

Event Type  Injury  

Manufacturer Narrative

Exact date unknown, event occurred over a month ago from the date the manufacturer was made aware.

Event Description

It was reported that the patient was not getting a relief and the ipg was no longer holding a charge.It was also reported that the patient was hospitalized and was given an isosorbide medication due to chest pain.It was noted that the high dose tetrahydrocannabinol seems to trigger the chest pain so patient is taking a lower dose and is currently doing much better.

Event Description

It was reported that the patient was not getting a relief and the ipg was no longer holding a charge.It was also reported that the patient was hospitalized and was given an isosorbide medication due to chest pain.It was noted that the high dose tetrahydrocannabinol seems to trigger the chest pain so patient is taking a lower dose and is currently doing much better.Additional information was received that the patient underwent an ipg replacement procedure and was doing well postoperatively.The explanted ipg will not be returned.

• 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
• MDR Report Key: 11904959
• MDR Text Key: 254303418
• Report Number: 3006630150-2021-02514
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729821526
• UDI-Public: 08714729821526
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/13/2017
• Device Model Number: SC-1132
• Device Catalogue Number: SC-1132
• Device Lot Number: 18174019
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 116