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

Model Number SC-1110-02

Device Problems Failure to Charge (1085); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 04/04/2019

Event Type  Injury  

Event Description

A report was received that the patient underwent an ipg replacement procedure for an unknown reason.

Event Description

A report was received that the patient underwent an ipg replacement procedure for an unknown reason.

Manufacturer Narrative

Additional information was received that the patients ipg was nonfunctional.The explanted device was not returned to bsn as it was discarded by the medical facility.A review of the manufacturing documentation for the device revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.

• Brand Name: PRECISION
• 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: 8575537
• MDR Text Key: 143890518
• Report Number: 3006630150-2019-02012
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767688
• UDI-Public: 08714729767688
• 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: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2010
• Device Model Number: SC-1110-02
• Device Catalogue Number: SC-1110-02
• Device Lot Number: 186833
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: 05/03/2019
• Supplement Dates FDA Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR