MAUDE Adverse Event Report: MPRI TBD; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	3708120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Refer to manufacturer report #2649622-2019-06691 for details pertaining to the reportable related event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer's representative and a healthcare provider (hcp) regarding a patient who was using a trialing system.It was reported that the patient had an infection during a buried lead trial and the surgery to place the internal battery was cancelled.The patient was placed on antibiotics.The infection was present at the site where their extensions were externalized.No further complications reported.

• Brand Name: TBD
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 8531975
• Report Number: 2649622-2019-06693
• Device Sequence Number: 16528282
• Product Code: LGW
• UDI-Device Identifier: 00643169887732
• UDI-Public: 00643169887732
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/19/2019

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: Health Professional
• Device Expiration Date: 02/06/2023
• Device Model Number: 3708120
• Device Catalogue Number: 3708120
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 04/19/2019
• 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: Other
• Patient Age: 72 YR