MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WAVEWRITER PROGRAMMER 5562-1; STIMULATOR, SPINAL-CORD TOTALLY IMPLANTED FOR PAIN RELIEF

Device Problem Component Missing (2306)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Per pt care coordinator, pt states she was in the hosp last week for surgery and remote bossci was lost.Pt reports she is in excruciating pain and is aware she is being emailed enrollment forms.

• Brand Name: WAVEWRITER PROGRAMMER 5562-1
• Type of Device: STIMULATOR, SPINAL-CORD TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 8470684
• MDR Text Key: 140582004
• Report Number: MW5085426
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization