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

Model Number 37714

Device Problems Break (1069); Connection Problem (2900)

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

Event Date 06/09/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97715, serial#: (b)(4), implanted: (b)(6) 2020, product type: implantable neurostimulator; product id: 39565-65, serial#: (b)(4), implanted: (b)(6) 2014, product type: lead.Other relevant device(s) are: product id: 39565-65, serial/lot#: (b)(4), ubd: 27-jun-2018, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The manufacturer representative reported that upon removing the leads from the previous implant, one was able to be removed and inserted into the new implant just fine while the other did not remove easily.The healthcare provider was able to heat the lead with warm water and eventually got the lead removed.The lead contacts appeared to be frayed upon removal and the healthcare provider was having difficulty inserting into the new implant.It was noted that the healthcare provider believes either fluid or blood may have gotten into the port and caused the lead to be damaged.Troubleshooting reviewed they can continue to insert the lead, but if it is physically compromised they may want to replace the lead.The representative stated that the lead was a surgical lead and if a replacement was required it would have to be done at a later time.No patient symptoms reported.Additional information received from the manufacturer representative reported that the healthcare professional was able to partially insert the lead.The physician inserted as much of the lead as possible while the other lead was able to be inserted all the way.The lead that was inserted properly had no impedances while the one that was partially inserted had two electrodes that were able to be used.The issue was resolved as the patient was programmed to get bilateral coverage and he was satisfied with the programming and level of pain relief he was getting.A replacement surgery was not scheduled.

• Brand Name: RESTORE SENSOR
• 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: 10192761
• MDR Text Key: 196440336
• Report Number: 3004209178-2020-10996
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994610430
• UDI-Public: 00613994610430
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2015
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2020
• Date Device Manufactured: 06/26/2014
• 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 Age: 44 YR
• Patient Weight: 118