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

Model Number SC-1432

Device Problems Premature Discharge of Battery (1057); Unexpected Therapeutic Results (1631); Battery Problem (2885); Wireless Communication Problem (3283)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/10/2021

Event Type  Injury  

Manufacturer Narrative

Approximated based on the date the manufacturer became aware of the event.Additional suspect medical device component involved in the event: product family: scs-paddle leads, upn: m365sc8352500, model: sc-8352-50, serial: (b)(4), batch: 2000014780.

Event Description

It was reported that the patient was not getting an adequate stimulation coverage.It was also noted that the ipg was nonfunctional and was having communication issues.The patient underwent spinal cord stimulator (scs) system replacement procedure and was doing well post operatively.

Manufacturer Narrative

Sc-1432 (sn: (b)(6)) the returned ipg was analyzed.Upon receiving, the device exhibits the eri (elective replacement indicator).The battery voltages were 2.749 volts by yack above the expressed eri threshold voltage.Eri will appear when the device battery level is below the expected range of 2.65 volts and will suspend normal operation with the end-of-service message.Lab analysis of the device did not reveal any anomalies.The energy use index (eui) for the settings was 100 and its estimated longevity is about 4-5 months.This device has generated an early eri message before the battery reaches below 2.65 volts (2.747 volts vs 2.65 volts).With all the available information, boston scientific concludes that the complaint was not confirmed.Sc-8352-50 (sn: (b)(6)) the returned lead was analyzed.A visual inspection found the lead was cleanly cut.No anomalies were identified on the lead aside from the clean-cut.The damage to the lead is a result of a typical explant procedure, and it is not considered a failure.

Event Description

It was reported that the patient was not getting an adequate stimulation coverage.It was also noted that the ipg was nonfunctional and was having communication issues.The patient underwent spinal cord stimulator (scs) system replacement procedure and was doing well post operatively.

• Brand Name: WAVEWRITER ALPHA PRIME
• 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: 12520051
• MDR Text Key: 272937004
• Report Number: 3006630150-2021-05334
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729985075
• UDI-Public: 08714729985075
• Combination Product (y/n): N
• 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: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/19/2022
• Device Model Number: SC-1432
• Device Catalogue Number: SC-1432
• Device Lot Number: 201665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR