MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97712

Device Problems Charging Problem (2892); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Fluid Discharge (2686)

Event Date 06/20/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical devices: product id: 977a160, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2016, product type: lead.Product id: 977a160, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2016, product type: lead.

Event Description

The healthcare professional (hcp) of a clinical study reported that there was wound dehiscence at the stimulator site.There was implantable neurostimulator (ins) wound site dehiscence and oozing yellow drainage.The wound was opened and the ins was exposed.The patient was sent to the local er for possible infection.An examination showed stimulator site wound dehiscence and infection.Interventions included explanting and replacing the system.The event resulted in in-patient hospitalization and an emergency room visit.The etiology was reported as related to the device or therapy and not related to the implant procedure.The etiology was reported as related to the implantable neurostimulator (ins) pocket.The outcome was resolved without sequelae.Relevant medical history included: non-malignant pain.

Manufacturer Narrative

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.

Event Description

Additional information received from the healthcare professional (hcp) of a clinical study reported that the outcome was resolved without sequelae.There was stimulator site wound dehiscence.

Manufacturer Narrative

Device received for analysis which had not yet begun.

Event Description

Additional information received reported the device was returned for analysis.

Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) showed no significant anomaly.The implantable neurostimulator (ins) was funct ionally okay with insignificant anomalies.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.

Manufacturer Narrative

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.

Manufacturer Narrative

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.

Event Description

Additional information was received from the healthcare professional of the clinical study.Prior to explant, the patient had gone through two rechargers and was still having problems with them on (b)(6) 2016.It was possibly related to the device or therapy (specifically the patient's usability issues) and not related to the implant procedure.No action was taken and there were no further reports of the charger issues before the explant that occurred on (b)(6) 2016.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H3: see regulatory report #3004209178-2016-14207 for device analysis.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.

Event Description

Additional information was received on 2023-07-07 reporting that the relationship of the event was not related to the device or therapy but was related to the implant procedure.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 5793974
• MDR Text Key: 49522326
• Report Number: 3004209178-2016-14207
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169109506
• UDI-Public: 00643169109506
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/11/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2016
• Initial Date Manufacturer Received: 06/22/2016
• Initial Date FDA Received: 07/14/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; 06/23/2017; 06/23/2017; 06/23/2017; 07/07/2023
• Supplement Dates FDA Received: 08/23/2016; 09/21/2016; 10/31/2016; 06/09/2017; 06/29/2017; 07/14/2017; 09/24/2017; 09/25/2017; 07/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 86 KG