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

Model Number	977C265
Medical Device Problem Codes	Break (1069); Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer representative (rep) concerning patient with implantable neurostimulator (ins) for non- malignant pain.It was reported healthcare provider (hcp) placed paddle lead for trial 1 week prior.During generator implantation on the date of the call, the hcp was disconnecting extensions from the paddle lead and the translucent cover over the connector got stuck while hcp was attempting to disconnect extension from paddle lead.The hcp was unable to get cover off to remove extension, so he pulled and caused the end of the paddle lead to fracture.A new paddle lead was simply and easily inserted into the patient and there are no issues other than that.No patient symptoms were reported.No further complications were reported/anticipated.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was reported that the patient's lead is staying as the doctor stated the placement looks good.The reps still cannot get coverage, but will be meeting with the patient for reprogramming.All options have been exhausted at this point.No further information was reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was reported that the physician does not believe that there is anything wrong with the ins or the lead and will not revise.He is considering this case closed.No further information was reported.
Additional Manufacturer Narrative
Continuation of d11: product id 977c265, serial# (b)(6), implanted: (b)(6) 2019, explanted: product type lead product id 97715, serial# (b)(6), implanted: (b)(6) 2019, explanted: product type implantable neurostimulator.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPECIFY SURESCAN
• 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: 9112306
• Report Number: 2649622-2019-17195
• Device Sequence Number: 3070342
• Product Code: LGW
• UDI-Device Identifier: 00643169464650
• UDI-Public: 00643169464650
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/05/2020

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: Health Professional
• Device Expiration Date: 08/26/2023
• Device Model Number: 977C265
• Device Catalogue Number: 977C265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 11/06/2019; 12/03/2019; 10/05/2020
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 12/02/2019; 12/16/2019; 10/05/2020
• 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
• Patient Age: 39 YR