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

Model Number	SC-3138-55
Medical Device Problem Codes	High impedance (1291); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Codes	Muscle Spasm(s) (1966); Undesired Nerve Stimulation (1980); No Code Available (3191)
Date of Event	02/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant date= (b)(6) 2018.
Event or Problem Description
A report was received that the patient experienced cramping in his abdomen below the ipg pocket site when stimulation was on.Reprogramming the device was attempted, but adequate pain coverage could not be achieved as there were high impedances on four contacts.Patient then underwent a revision procedure where the extension was replaced.Patient is fine post-operatively, and all impedances are within normal limits.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, x-ray inspection of the lead extension revealed cables 5, 6, 7 and 8 were fractured after the weld in the distal connector stack.This type of damage typically occurs when excessive tensile force is exerted onto the lead body and connector section of the lead.Bending the distal end could also cause cable fractures in the connector section of the lead.The broken cables are still contained inside the connector.The device history record confirmed that the devices met all material, assembly and performance specifications.
Event or Problem Description
A report was received that the patient experienced cramping in his abdomen below the ipg pocket site when stimulation was on.Reprogramming the device was attempted, but adequate pain coverage could not be achieved as there were high impedances on four contacts.Patient then underwent a revision procedure where the extension was replaced.Patient is fine post-operatively, and all impedances are within normal limits.

• Brand Name: NA
• 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: 9781949
• Report Number: 3006630150-2020-00941
• Device Sequence Number: 19534785
• Product Code: LGW
• UDI-Device Identifier: 08714729760566
• UDI-Public: 08714729760566
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/11/2018
• Device Model Number: SC-3138-55
• Device Catalogue Number: SC-3138-55
• Device Lot Number: 18765281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 04/29/2020
• 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