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); Charging Problem (2892); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Irritation (1941); Pain (1994); No Code Available (3191)

Event Date 05/08/2020

Event Type  Injury  

Event Description

It was reported that the patient was experiencing rib pain due to the ipg placement.The physician administered an intercostal nerve block.No further action will be taken at this time.

Event Description

It was reported that the patient was experiencing rib pain due to the ipg placement.The physician administered an intercostal nerve block.No further action will be taken at this time.Additional information was received that the patient was never administered an injection by the physician to help with the ipg site pain.The ipg in the patients left armpit area was protruding and was causing irritation.There was no skin breakage noted.The area had become tender and could not be touched.It was also reported that the patients ipg would not charge properly and the patient experienced inadequate stimulation.All components were explanted and were not returned.The patient was doing well postoperatively.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2317700, model: sc-2317-70, serial: (b)(6), batch: (b)(6).

• 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: 10083981
• MDR Text Key: 191866447
• Report Number: 3006630150-2020-02196
• 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
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/18/2021
• Device Model Number: SC-1160
• Device Catalogue Number: SC-1160
• Device Lot Number: 358478
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR