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

Model Number SC-8336-50

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Numbness (2415)

Event Date 06/15/2021

Event Type  Injury  

Event Description

It was reported that following an implant procedure, the patient could not feel anything from the chest down.A computerized tomography scan was taken and showed there was no bleeding.The physician believed it was not device related but the patient may have rolled wrong and some spinal cord swelling was pressing the nerves.The patient was taking high dose of steroids and was sent in a rehabilitation unit while waiting for the swelling to go down.

Event Description

It was reported that following an implant procedure, the patient could not feel anything from the chest down.A computerized tomography scan was taken and showed there was no bleeding.The physician believed it was not device related but the patient may have rolled wrong and some spinal cord swelling was pressing the nerves.The patient was taking high dose of steroids and was sent in a rehabilitation unit.Additional information was received that the patients feeling in the back and abdomen has now been regained.

• Brand Name: COVEREDGE 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: 12123621
• MDR Text Key: 260261502
• Report Number: 3006630150-2021-03551
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729832669
• UDI-Public: 08714729832669
• 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: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/21/2023
• Device Model Number: SC-8336-50
• Device Catalogue Number: SC-8336-50
• Device Lot Number: 7074492
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR