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

Model Number	SC-9218-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); No Code Available (3191)
Date of Event	07/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: model number/catalog number:sc-9218-15, serial number: (b)(4), batch/lot number: 7018165, model/catalog description: precision m8 adapter 15cm.Model number/catalog number: sc-1160, serial number: (b)(4), batch/lot number: 334550, model/catalog description: spectra wavewriter ipg kit.It is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint devices could not be completed.A review of the device history records will be conducted.If there are any further relevant information from that review, a supplemental med watch will be filed.
Event or Problem Description
A report was received that the patients m8 adapter was sticking out through the skin.The patient was placed on antibiotics and underwent a revision procedure wherein the incision was opened and tucked the m8 adapter behind the ipg.The patient was doing well postoperatively.

• 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: 8826770
• Report Number: 3006630150-2019-03820
• Device Sequence Number: 2575952
• Product Code: LGW
• UDI-Device Identifier: 08714729888734
• UDI-Public: 08714729888734
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/24/2020
• Device Model Number: SC-9218-15
• Device Catalogue Number: SC-9218-15
• Device Lot Number: 7017864
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 07/25/2019
• 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: Required Intervention
• Patient Age: 42 YR