MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION COVEREDGE X 32; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-8352-70

Device Problem Migration (4003)

Patient Problems Incontinence (1928); Undesired Nerve Stimulation (1980); Neurological Deficit/Dysfunction (1982); Device Overstimulation of Tissue (1991); Pain (1994); Swelling (2091); Urinary Retention (2119); Numbness (2415); No Code Available (3191)

Event Date 09/26/2018

Event Type  Injury  

Manufacturer Narrative

The explanted device was not returned to bsn as it was kept by the medical facility.

Event Description

A report was received that the patients lead had migrated and was laying on some nerves that caused unwanted stimulation.The patient underwent a lead replacement procedure and was doing well postoperatively.

Event Description

A report was received that the patients lead had migrated and was laying on some nerves that caused unwanted stimulation.The patient underwent a lead replacement procedure and was doing well postoperatively.Additional information was received that the patient experienced pain due to the lead migration.It was also reported that the patient had experienced overstimulation down the patients spine, loss of bowel control, urinary retention, drop foot, loss of ambulation, swelling in the limbs and numbness in the patients arm and leg.

• Brand Name: COVEREDGE X 32
• 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: 7974497
• MDR Text Key: 123996126
• Report Number: 3006630150-2018-61312
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729832690
• UDI-Public: 08714729832690
• 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: 10/20/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/22/2020
• Device Model Number: SC-8352-70
• Device Catalogue Number: SC-8352-70
• Device Lot Number: 7007748
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/27/2018
• Initial Date FDA Received: 10/17/2018
• Supplement Dates Manufacturer Received: 10/01/2020
• Supplement Dates FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR