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

Model Number SC-1160

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Pain (1994); Seroma (2069); No Code Available (3191)

Event Date 03/01/2020

Event Type  Injury  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Model number/catalog number: sc-8336-50, serial number: (b)(4), batch/lot number: 7070195, model/catalog description: coveredge 32 surgical lead kit 50 cm.

Event Description

A report was received that the patient underwent a procedure to drain the fluid that was collecting around the ipg site and causing pain.The physician confirmed that the fluid was clear and infection was not suspected.The patient underwent a second procedure to collect fluid around the ipg site again.The physician then confirmed that it was spinal fluid that was most likely draining down the leads and pooling in the ipg pocket.The physician did not suspect device malfunction.

Event Description

A report was received that the patient underwent a procedure to drain the fluid that was collecting around the ipg site and causing pain.The physician confirmed that the fluid was clear and infection was not suspected.The patient underwent a second procedure to collect fluid around the ipg site again.The physician then confirmed that it was spinal fluid that was most likely draining down the leads and pooling in the ipg pocket.The physician did not suspect device malfunction.

• Brand Name: SPECTRA WAVEWRITER
• 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: 10015404
• MDR Text Key: 189614331
• Report Number: 3006630150-2020-01936
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729951254
• UDI-Public: 08714729951254
• 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: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/08/2021
• Device Model Number: SC-1160
• Device Catalogue Number: SC-1160
• Device Lot Number: 353158
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR