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

Model Number SC-1110-02

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); No Code Available (3191)

Event Date 02/21/2019

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model: sc-2218-50, serial/lot: (b)(4) and (b)(4), description: linear st lead kit 50 cm.Model: sc-4316, serial/lot: (b)(4), description: clik anchor.

Event Description

A report was received that the patient developed a hematoma near the ipg.The hematoma subsided however a wound appeared with drainage and opened where the ipg could be seen.The physician explanted the scs system as a precaution.The patient also developed a local infection which was treated with antibiotics.

Event Description

A report was received that the patient developed a hematoma near the ipg.The hematoma subsided however a wound appeared with drainage and opened where the ipg could be seen.The physician explanted the scs system as a precaution.The patient also developed a local infection which was treated with antibiotics.

Manufacturer Narrative

Additional information was received that the explanted devices were disposed by the medical facility.A review of the manufacturing documentation for the devices 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: 8630184
• MDR Text Key: 145734476
• Report Number: 3006630150-2019-02387
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/02/2017
• Device Model Number: SC-1110-02
• Device Catalogue Number: SC-1110-02
• Device Lot Number: 17648347
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention