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

Model Number 97715

Device Problems Disconnection (1171); High impedance (1291)

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

Event Date 12/26/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 377760, lot#: v010867, implanted: (b)(6) 2006, product type: lead.Product id: 37711, serial#: (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2019, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) regarding a patient who was implanted with an implantable neurostimulator (ins) for complex regional pain syndrome type i and spinal pain via a manufacturer¿s representative (rep).The rep reported that the patient wasn't experiencing any symptoms.The patient was getting good stimulation coverage prior to end of service (eos) of battery which occurred sometime in (b)(6) 2019.The rep reported that upon replacing the ins on (b)(6) 2019, it was noted that one of the leads wasn't in the ins, it was just sitting outside the generator in the pocket.The rep reported that when replacing to a new ins and checking impedances, the lead which was seated in the 8-15 port had impedances all greater than 40,000 ohms.The rep reported that no interventions were taken today by the hcp.The ins was replaced.The rep reported that the hcp would take the patient back to surgery to replace the lead if needed at a later time.The rep noted that since the previous ins was at eos, no previous impedances or programmed settings were available for comparison.There were no factors known that could have contributed to the issue.The rep noted that the issues were found the day of the report.No further complications were reported.

Event Description

Additional information received from a manufacturer representative (rep).It was reported that the hcp expected the lead to be seeded in the ins when he opened the pocket upon replacement surgery.The lead was not in the ins at all, it had come dislodged from the ins.It was unknown if it was not tightened properly before and it came out of the ins.The cause of the high impedances was not determined.No actions were taken to resolve the high impedance.The hcp put the lead into the new ins and will bring the patient back for a lead revision at a later time if needed.This lead was not being used for patient management.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: 9582694
• MDR Text Key: 175021354
• Report Number: 3004209178-2020-00928
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2020
• Date Device Manufactured: 09/10/2019
• 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: 58 YR
• Patient Weight: 77