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

Model Number 97715

Device Problems Break (1069); High impedance (1291); Connection Problem (2900); Material Deformation (2976)

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

Event Date 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 39565-65, serial#: (b)(4), implanted: (b)(6) 2010, product type: lead.Other relevant device(s) are: product id: 39565-65, serial/lot #: (b)(4), ubd: 11-jun-2014, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported that the patient had a routine battery replacement on (b)(6) 2019.When the hcp tried to remove the 8-15 lead tail from the old battery, the lead would not even budge even though the torque screw was fully backed off.The hcp fully torqued the set screw and again backed it off, but the lead tail would not easily pull out from the old battery.Using a great amount of force, the hcp was able to remove the lead tail.However, the lead tail looked like something had crimped it on about the 5th contact.There was a visible bend and roughness on the exterior sheath of the lead.The hcp removed the roughness with a scalpel and tried inserting the lead into the new battery several times.Only with the assistance of a needle driver was the hcp able to insert the lead tail into an extension.The rep took several readings of impedances to see if the lead was fully inserted.The best they were able to get was 7 of the 8 contacts inserted, with all 7 of those properly seated and only one contact showing high impedances.No further complications were reported.

• 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: 9254987
• MDR Text Key: 177373266
• Report Number: 3004209178-2019-20683
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2019
• Initial Date FDA Received: 10/30/2019
• Date Device Manufactured: 11/29/2018
• 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: 73 YR