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

Model Number SC-1132

Device Problems Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574); Delayed Charge Time (2586); Charging Problem (2892)

Patient Problems Skin Irritation (2076); Discomfort (2330); No Code Available (3191)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Exact date unknown, event occurred in (b)(6) 2020.

Event Description

It was reported that the patients ipg was not holding a charge and was taking longer to charge.It was also reported that during charging sessions, the ipg site would get warm and the patient felt shocking sensations.The ipg pocket was also irritated and sensitive to the touch.Database analysis revealed no anomalies.The patient underwent a revision procedure wherein the ipg was replaced and relocated.The patient 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 10665313
• MDR Text Key: 211017806
• Report Number: 3006630150-2020-04803
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2018
• Device Model Number: SC-1132
• Device Catalogue Number: SC-1132
• Device Lot Number: 18934516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2016
• 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: 56 YR