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

Model Number SC-1132

Device Problems Device Inoperable (1663); Defective Device (2588)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 05/03/2018

Event Type  Injury  

Event Description

A report was received that the patients ipg was non-functional.The will undergo an explant procedure.

Manufacturer Narrative

Additional information was received that the patient was going on a lot of health issues thus wanted the scs devices removed.The patient needed cardiac clearance before scs can be removed.No further course of action will be taken at this time.A review of the manufacturing documentation for the device revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.

Event Description

A report was received that the patients ipg was non-functional.The patient will undergo an explant procedure.

Manufacturer Narrative

Model number/catalog number: sc-8352-50, serial number: (b)(4), batch/lot number: 20346196, model/catalog description: coveredge x 32 surgical lead kit 50 cm.The explanted devices were not returned to bsn as they were kept by medical facility.

Event Description

A report was received that the patients ipg was non-functional.The patient will undergo an explant procedure.

• 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 CLONMEL LIMITED; cashel road; ,; clonmel CA ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; ,; valencia, CA 91355 ; 6619494863
• MDR Report Key: 7543195
• MDR Text Key: 109228457
• Report Number: 3006630150-2018-01791
• 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,Followup,Followup
• Report Date: 07/26/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/21/2018
• Device Model Number: SC-1132
• Device Catalogue Number: SC-1132
• Device Lot Number: 19984447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2018
• Initial Date FDA Received: 05/24/2018
• Supplement Dates Manufacturer Received: 05/29/2018; 07/09/2019
• Supplement Dates FDA Received: 06/12/2018; 07/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2016
• 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: 82 YR