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

Model Number	SC-1160
Medical Device Problem Codes	Charging Problem (2892); Positioning Problem (3009)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/27/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A report was received that the patient was experiencing difficulty charging her ipg.The patient underwent an ipg revision procedure wherein the ipg was relocated.The patient was doing well postoperatively.
Additional Manufacturer Narrative
Correction to the initial mdr in fields h6: device code and d4.
Event or Problem Description
A report was received that the patient was experiencing difficulty charging her ipg.The patient underwent an ipg revision procedure wherein the ipg was relocated.The patient was doing well postoperatively.

• Brand Name: SPECTRA WAVEWRITER
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 8264093
• Report Number: 3006630150-2019-00116
• Device Sequence Number: 14042813
• Product Code: LGW
• UDI-Device Identifier: 08714729764465
• UDI-Public: 08714729764465
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/17/2020
• Device Model Number: SC-1160
• Device Catalogue Number: SC-1160
• Device Lot Number: 340186
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 01/21/2019
• Supplement Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR