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

Model Number	SC-5312
Medical Device Problem Codes	No Display/Image (1183); Overheating of Device (1437); Charging Problem (2892)
Health Effect - Clinical Codes	Pain (1994); Inadequate Pain Relief (2388)
Date of Event	08/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device analysis of the charger revealed that the chargers fuse had blown which is why it was not charging in the base station.
Event or Problem Description
A report was received that the patient was hospitalized due to pain exacerbation.It was reported that the charger was beeping even when properly lined up over the ipg.The led screen off the charger remained orange.The charger also became warm thereby making charging the internal ipg difficult, and causing it to deplete.The patient had an out-patient stay, and was provided with a replacement charger.The patient has regained pain therapy with the replacement charger.Per the information provided no medical intervention was provided during the out-patient stay.
Additional Manufacturer Narrative
Additional information was received that the aware date of the initial mdr was (b)(4) 2018.
Event or Problem Description
A report was received that the patient was hospitalized due to pain exacerbation.It was reported that the charger was beeping even when properly lined up over the ipg.The led screen off the charger remained orange.The charger also became warm thereby making charging the internal ipg difficult, and causing it to deplete.The patient had an out-patient stay, and was provided with a replacement charger.The patient has regained pain therapy with the replacement charger.Per the information provided no medical intervention was provided during the out-patient stay.
Additional Manufacturer Narrative
A review of the manufacturing documentation for the charger revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.
Event or Problem Description
A report was received that the patient was hospitalized due to pain exacerbation.It was reported that the charger was beeping even when properly lined up over the ipg.The led screen off the charger remained orange.The charger also became warm thereby making charging the internal ipg difficult, and causing it to deplete.The patient had an out-patient stay, and was provided with a replacement charger.The patient has regained pain therapy with the replacement charger.Per the information provided no medical intervention was provided during the out-patient stay.

• 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: 7991699
• Report Number: 3006630150-2018-61456
• Device Sequence Number: 13896665
• Product Code: LGW
• UDI-Device Identifier: 08714729764465
• UDI-Public: 08714729764465
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2019

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 Model Number: SC-5312
• Device Catalogue Number: SC-5312
• Device Lot Number: 15616058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 11/06/2018; 08/28/2019
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 11/26/2018; 09/24/2019
• 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: Hospitalization