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

Model Number SC-1160

Device Problem Migration (4003)

Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Fluid Discharge (2686)

Event Date 12/10/2020

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: scs-linear leads, upn: m365sc2218500, model: sc-2218-50, serial: (b)(4), batch: 7080439/7080875.

Event Description

It was reported that the patient developed an infection and the stimulator had shifted.It was also reported that the patient had a minor wound dehiscence and a fluid discharged.The patient was prescribed with medication.

Event Description

It was reported that the patient developed an infection and the stimulator had shifted.It was also reported that the patient had a minor wound dehiscence and a fluid discharged.The patient was prescribed with medication.Additional information was received that the infection was on the ipg site and it was due to patients poor hygiene.The physician believed that the infection was not device related and unknown if procedure related.The patient was prescribed antibiotics.The physician stapled the site and trying to correct infection.

Event Description

It was reported that the patient developed an infection and the stimulator had shifted.It was also reported that the patient had a minor wound dehiscence and a fluid discharged.The patient was prescribed with medication.Additional information was received that the infection was on the ipg site and it was due to patients poor hygiene.The physician believed that the infection was not device related and unknown if procedure related.The patient was prescribed antibiotics.The physician stapled the site and trying to correct infection.Additional information was received that the patient still has infection at the ipg site.Symptoms of swelling and puss coming from the implant site were noted.The patient was on fourth round of antibiotics to correct the infection.

Event Description

It was reported that the patient developed an infection and the stimulator had shifted.It was also reported that the patient had a minor wound dehiscence and a fluid discharged.Culture was taken and has grown some bacterium.The patient was prescribed with medication.Additional information was received that the infection was on the ipg site and it was due to patients poor hygiene.The physician believed that the infection was not device related and unknown if procedure related.The patient was prescribed antibiotics.The physician stapled the site and trying to correct infection.Additional information was received that the patient still has infection at the ipg site.Symptoms of swelling and puss coming from the implant site were noted.The patient was on fourth round of antibiotics to correct the infection.Additional information was received that the patients ipg and leads were explanted.The patient was doing well postoperatively.The explanted ipg was discarded.No further information has been obtained despite good faith efforts.

• 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: 11333467
• MDR Text Key: 232017385
• Report Number: 3006630150-2021-00495
• 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,Followup,Followup
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/21/2022
• Device Model Number: SC-1160
• Device Catalogue Number: SC-1160
• Device Lot Number: 373629
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 104