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

Model Number SC-1160

Device Problems Charging Problem (2892); Migration (4003)

Patient Problems Edema (1820); Fall (1848); Pain (1994); No Code Available (3191)

Event Date 02/21/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient was experiencing difficulty charging following a revision procedure.The physician noticed that the ipg was slightly tilted and tangible.It was also stated that the patient was experiencing pain at the pocket site which radiated down the left lower extremity.The physician believed that the patient had popped out internal sutures that were used to tighten the old pocket site.No malfunction was suspected.The patients ipg was replaced and the pocket site was relocated.The patient was doing well postoperatively.The explanted ipg will not be returned.

• 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: 10288397
• MDR Text Key: 199234901
• Report Number: 3006630150-2020-02965
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/11/2020
• Device Model Number: SC-1160
• Device Catalogue Number: SC-1160
• Device Lot Number: 347418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2018
• 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: 40 YR