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

Model Number SC-1232

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

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 08/17/2021

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: m365sc2218700, model: sc-2218-70, serial: (b)(4), batch: 7076663/7080210.Product family: scs-lead fixation, upn: m365sc43180, model: sc-4318, serial: n/a, batch: 27370037.

Event Description

It was reported that the patient developed an infection.The patient was admitted to the hospital and underwent a spinal cord stimulator (scs) system explant procedure.The explanted scs system was discarded.The physician did not suspect the integrity of the scs system.No further information has been obtained despite good faith efforts.

Event Description

It was reported that the patient developed an infection.The patient was admitted to the hospital and underwent a spinal cord stimulator (scs) system explant procedure.The explanted scs system was discarded.The physician did not suspect integrity of the scs system.No further information has been obtained despite good faith efforts.Additional information was received that the physician did not think that the infection was related to the device nor the surgery had caused it.The patient was placed on antibiotics.

• Brand Name: WAVEWRITER ALPHA
• 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: 12448238
• MDR Text Key: 270600837
• Report Number: 3006630150-2021-05069
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729985099
• UDI-Public: 08714729985099
• 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: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/09/2023
• Device Model Number: SC-1232
• Device Catalogue Number: SC-1232
• Device Lot Number: 506588
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR