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

Model Number SC-1160

Device Problem Charging Problem (2892)

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

Event Date 05/30/2020

Event Type  Injury  

Manufacturer Narrative

Exact date unknown, event occurred three months ago after the previous revision procedure.

Event Description

It was reported that the patient had a fluid around the implant site which caused the difficulty in charging the ipg.The physician believed that the fluid was a spinal fluid leaking from a small hole in the dura.No infection was noted and it is not device related.It was also noted that the patient had a revision procedure prior to this event three months ago to drain the fluid (mfr: 3006630150-2020-01936) however, it returned.

Event Description

It was reported that the patient had a fluid around the implant site which caused the difficulty in charging the ipg.The physician believed that the fluid was a spinal fluid leaking from a small hole in the dura.No infection was noted and it is not device related.It was noted that the patient had a revision procedure prior to this event three months ago to drain the fluid (mfr: 3006630150-2020-01936) however, it returned.Additional information was received that the physician was able to drain the fluid from the ipg site.

• 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: 10565204
• MDR Text Key: 207891148
• Report Number: 3006630150-2020-04378
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• 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: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR