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 Irritation (1941); No Code Available (3191)

Event Date 02/07/2020

Event Type  Injury  

Manufacturer Narrative

The explanted device was not returned to bsn as it was discarded by the medical facility.

Event Description

A report was received that the patient was experiencing discomfort at the ipg site when charging.It was also noted that the battery would never show fully charged on the remote control.The patient a revision procedure wherein the pocket site was revised and the ipg was replaced.

Event Description

A report was received that the patient was experiencing discomfort at the ipg site when charging.It was also noted that the battery would never show fully charged on the remote control.The patient underwent a revision procedure wherein the pocket site was revised and the ipg was replaced.

Manufacturer Narrative

Additional information was received that the patients battery issue was due to charging puck not being fully charged.The patient was doing well postoperatively.

• 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: 9779395
• MDR Text Key: 181734368
• Report Number: 3006630150-2020-00928
• 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: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/28/2018
• Device Model Number: SC-1132
• Device Catalogue Number: SC-1132
• Device Lot Number: 19770480
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR