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

Model Number	SC-1112
Medical Device Problem Codes	Overheating of Device (1437); Charging Problem (2892)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	11/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exact date unknown, implant occurred in 2016.
Event or Problem Description
It was reported the patient experienced more frequent charging for extended periods of time resulting in overheating and swelling at the implantable pulse generator (ipg) pocket site.The physician assessed that the ipg may be coming to the end of life as the patient had been running high rate programs for most of the life of the device.No further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported the patient experienced more frequent charging for extended periods of time resulting in overheating and swelling at the implantable pulse generator (ipg) pocket site.The physician assessed that the ipg may be coming to the end of life as the patient had been running high rate programs for most of the life of the device.No further information has been obtained despite good faith efforts.Additional information received reported the patient underwent an explant procedure to remove the device, and did well post-operatively.
Additional Manufacturer Narrative
Based on all the available information, engineers concluded that the event of frequent charging for extending periods of time and overheating of the implantable pulse generator (ipg) could not be confirmed with device analysis.A review of the patient's data found no charging anomalies, and the battery depletion rate without using stimulation was within the expected range.However, the data also revealed constant high power stimulation was in use, and that would require frequent and extended charging time.Additionally, the charge profile showed the maximum temperature during charging was within the tolerance limit.Monitored stimulation found output consistent and correct on all electrodes, and current leakage tests and residual gas analysis verified no loss of electric current into the surrounding tissue.However, a labeling review indicated that the reported skin swelling at the ipg site can occur over time and is a known risk of using the device.
Event or Problem Description
It was reported the patient experienced more frequent charging for extended periods of time resulting in overheating and swelling at the implantable pulse generator (ipg) pocket site.The physician assessed that the ipg may be coming to the end of life as the patient had been running high rate programs for most of the life of the device.No further information has been obtained despite good faith efforts.Additional information received reported the patient underwent an explant procedure to remove the device, and did well post-operatively.

• Brand Name: PRECISION
• 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: 11829447
• Report Number: 3006630150-2021-02148
• Device Sequence Number: 11027666
• Product Code: LGW
• UDI-Device Identifier: 08714729837138
• UDI-Public: 08714729837138
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2021

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: 07/31/2017
• Device Model Number: SC-1112
• Device Catalogue Number: SC-1112
• Device Lot Number: 18130333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 06/04/2021; 07/15/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 06/10/2021; 07/29/2021
• 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