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

Model Number 97712

Device Problems Break (1069); High impedance (1291); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

Product id 39286-65, serial# (b)(4), implanted: (b)(6) 2014.Product type lead correction: product problem correction: malfunction if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturer representative (rep) reporting that the ins replacement and lead fracture were first observed on (b)(6) 2020 it was indicated that the reason for the ins replacement was due to the device nearing end of service.The cause of the fractured lead during the ins replacement was not determined, but the rep reported that the surgeon said it seemed like the insulation of the lead was ¿swollen¿.No further actions were taken to resolve the fractured lead.The lead would not be returned as it remains implanted in the patient.The ins was mailed back on (b)(6) 2020.It was indicated that the provided information had been confirmed with the physician.No further complications were reported/anticipated.

Manufacturer Narrative

Concomitant medical products: product id: 39286-65, serial# (b)(4), implanted: (b)(6) 2014,product type: lead.Other relevant device(s) are: product id: 39286-65, serial/lot #: (b)(4), ubd: 31-mar-2018, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) concerning patient with an implantable neurostimulator (ins).It was reported the lead was stuck in an old ins and fracture when removed.The patient reported post-op that she frequently uses a heating pad, but never over the ins site.Impedance check showed high impedances 8-15, normal impedance on 0-7.No patient symptoms were reported.No further complications were reported/anticipated.

Manufacturer Narrative

Product id: 97712.The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The returned device passed all testing in the laboratory and no anomalies were identified.Product id: 39286-65 the returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Analysis identified environmentally assisted degradation of the insulation at the proximal end of the lead.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 9700483
• MDR Text Key: 186639742
• Report Number: 3004209178-2020-03179
• Device Sequence Number: 1
• Product Code: LGW
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2015
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/16/2014
• 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): Required Intervention
• Patient Age: 78 YR