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

Model Number SC-1132

Device Problems Unexpected Therapeutic Results (1631); Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported that the patient underwent an explant procedure after the patient had an unrelated knee surgery which is believed to have damaged the spinal cord stimulator as the patient could not receive therapy anymore following the knee surgery.

Manufacturer Narrative

Corrections to fields b5 and h10.The device was not returned for analysis and the complaint of loss of stimulation could not be confirmed.Record review revealed no additional information related to the complaint.The investigation is unable to determine a probable cause for the complaint; therefore, the cause cannot be established.

Event Description

It was reported that following a non-device related surgery the patient lost therapy.The physician assessed the surgery may have damaged the ipg, therefore, the patient underwent an explant procedure.No further information can be obtained regarding the implant date, physician, patient status, or return of the device despite good faith efforts.

• 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: 10341540
• MDR Text Key: 201520260
• Report Number: 3006630150-2020-03160
• 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
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2017
• Device Model Number: SC-1132
• Device Catalogue Number: SC-1132
• Device Lot Number: 17648358
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention