MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION WAVEWRITER ALPHA PRIME 16; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-1416

Device Problem Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2022

Event Type  Injury  

Event Description

It was reported that the patients ipg had reached end of life.The patient underwent an ipg replacement procedure and was doing well postoperatively.

Manufacturer Narrative

Approximated based on the date the manufacturer became aware of the event.

Manufacturer Narrative

Sc-1416, sn: (b)(6).The returned ipg was analyzed, and the primary cell battery has reached the elective replacement indicator (eri) stage when the battery voltage reached 2.75v after 315 days or 10 months in service.Based on the latest energy use index eui of 63.3, the ipg should last 8plus months, which matches the actual number of days it lasted before the eri message was received.A review of the patient data revealed no anomalies.Lab analysis of the device did not reveal any anomalies.

Event Description

It was reported that the patients ipg had reached end of life.The patient underwent an ipg replacement procedure and was doing well postoperatively.

• Brand Name: WAVEWRITER ALPHA PRIME 16
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 15287483
• MDR Text Key: 298556970
• Report Number: 3006630150-2022-04264
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729985068
• UDI-Public: 08714729985068
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2023
• Device Model Number: SC-1416
• Device Catalogue Number: SC-1416
• Device Lot Number: 205197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 81 KG