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

Model Number 97715

Device Problems Charging Problem (2892); Connection Problem (2900); Material Integrity Problem (2978)

Patient Problem Chest Pain (1776)

Event Date 01/29/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37751, serial#: (b)(4), product type: recharger.Product id: 37761, serial#: (b)(4), product type: recharger.Other relevant device(s) are: product id: 37761, serial/lot #: (b)(4).Analysis of the desktop charger (serial #: (b)(4)) found that the cable assembly had damaged connector pins, as they were broken and bent.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient via manufacturer representative.It was reported that the patient¿s recharger connection site was damaged and the desktop charger had a damaged connector pin.The manufacturer representative stated that the recharger was not taking a charge.It was reported that the patient¿s recharger was not taking a charge and they were unable to use their implantable neurostimulator (ins), and they were experiencing chest pains because of this.The repair department was contacted and a replacement desktop charger and recharger were requested.Additional information was received from a manufacturer representative on 2020-mar-05.It was reported that the patient's external device issues and chest pains had been resolved.No further complications were reported or anticipated.Indications for use are angina and non-malignant pain.

• Brand Name: INTELLIS
• 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: 9912485
• MDR Text Key: 186017613
• Report Number: 3004209178-2020-06545
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Date Manufacturer Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2020
• 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: 70 YR