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

Model Number 97714

Device Problems Display or Visual Feedback Problem (1184); Charging Problem (2892); Connection Problem (2900); Material Integrity Problem (2978); Operating System Becomes Nonfunctional (2996)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37761, serial#: (b)(4), product type: recharger.Other relevant device(s) are: product id: 37761, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient.It was reported that there was a loose connector pin on the desktop charger.On the date of this report, the patient plugged the recharger into the wall to charge and later when they went to charge their implantable neurostimulator (ins), they noticed that the recharger screen was blank and the device was unresponsive.The patient stated that the green light on the desktop charger was on and that they had tried multiple outlets but the recharger was not taking a charge.Since the patient could not charge their ins, they now had a return of symptoms.Troubleshooting steps were performed during the call and the patient noticed that the connector pin was wiggly.The repair department was contacted and a replacement desktop charger was requested.No further complications were reported or anticipated.Indication for use is spinal pain.

Manufacturer Narrative

Analysis of the desktop charger (serial# (b)(4)) found bent connector pins.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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9759420
• MDR Text Key: 181337574
• Report Number: 3004209178-2020-04154
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Date Manufacturer Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2017
• 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 Age: 43 YR