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

Model Number SC-1160

Device Problems Unexpected Therapeutic Results (1631); Wireless Communication Problem (3283)

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

Event Date 11/13/2021

Event Type  Injury  

Event Description

It was reported that the patient experienced loss stimulation and difficulty communicating ipg to remote.The patient underwent a revision procedure wherein the old ipg was replaced with a magnetic resonance imaging (mri) compatible one.The patient was doing well postoperatively.

Manufacturer Narrative

Date of event: exact date unknown, event occurred weekend before the date the manufacturer became aware of the event.

Manufacturer Narrative

Sc-1160 (sn: (b)(6).The returned ipg was analyzed and the device was undetectable nor charged.The battery was depleted (1.49 volts).An internal electrical test found u2 asic (application-specific integrated circuit) was damaged and leaking excessive current (45.28 ma) with thermal (36.5c) on its surface.With all the available information, boston scientific concludes that the reported event was confirmed.An internal electrical test found asic u2 has been damaged similar to this type of damage exposure to high-voltage transients or high rf (radio frequency) energy.

Event Description

It was reported that the patient experienced loss stimulation and difficulty communicating ipg to remote.The patient underwent a revision procedure wherein the old ipg was replaced with a magnetic resonance imaging (mri) compatible device.The patient was doing well postoperatively.

• 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
• 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: 13076849
• MDR Text Key: 282707045
• Report Number: 3006630150-2021-07208
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729951254
• UDI-Public: 08714729951254
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030017
• 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: 05/06/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/28/2020
• Device Model Number: SC-1160
• Device Catalogue Number: SC-1160
• Device Lot Number: 341854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 04/14/2022
• Supplement Dates FDA Received: 05/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2018
• 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: 35 YR
• Patient Sex: Female