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

Model Number SC-1160

Device Problems Delayed Charge Time (2586); Migration (4003)

Patient Problems Bacterial Infection (1735); Purulent Discharge (1812); Fever (1858); Inflammation (1932); Pain (1994); Rash (2033); Swelling (2091)

Event Date 07/30/2019

Event Type  Injury  

Manufacturer Narrative

Approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: linear st lead kit 50 cm, upn: (b)(4), model: sc-2218-50, serial: (b)(4), batch: 5105222/5085447.

Event Description

It was reported that the patient had an active infection that was oozing from the back.The patient also experienced a bolt of lightning pain and tenderness at the ipg site.Symptoms of redness, swelling, bruises, fluid discharges and fever were noted.The patient underwent and explant procedure and was doing well postoperatively.All explanted device components were discarded.

Event Description

It was reported that the patient had an active infection that was oozing from the back.The patient also experienced a bolt of lightning pain and tenderness at the ipg site.Symptoms of redness, swelling, bruises, fluid discharges and fever were noted.The patient underwent and explant procedure and was doing well postoperatively.All explanted device components were discarded.Additional information was received that the infection was located at the ipg site.The physician believed that the infection was not device or procedure related and it started somewhere else in the patients body.The patient was placed on intravenous antibiotics.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: linear st lead kit 50 cm, upn: m365sc2218500, model: sc-2218-50, serial: (b)(6), batch: 5105222/5085447.

• 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: 10494643
• MDR Text Key: 205688998
• Report Number: 3006630150-2020-03928
• 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: 09/24/2020

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: 11/13/2020
• Device Model Number: SC-1160
• Device Catalogue Number: SC-1160
• Device Lot Number: 346630
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/04/2020
• Supplement Dates Manufacturer Received: 09/04/2020
• Supplement Dates FDA Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR