MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bronchitis (1752); Patient Problem/Medical Problem (2688)

Event Date 01/28/2019

Event Type  Injury  

Event Description

Pt states he was in the hospital twice in the past two months for 5-6 days for bronchitis/flu like symptoms.Pt reports he is feeling well.Pt states he is still undergoing physical therapy and reports amputation he had long before the stimulator was implanted.He is aware fc is working on obtaining replacement remote.

• Brand Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 8301321
• MDR Text Key: 135740729
• Report Number: MW5083657
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/28/2019

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
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 67 YR