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

Model Number 97715

Device Problems High impedance (1291); Device Difficult to Program or Calibrate (1496)

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

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturing representative (rep) regarding the patient.The rep reported high impedances.They stated that during a routine reprogramming check, they noticed that there were issues using some contacts.The rep then ran an impedance check and discovered that 2 contacts (11 and 12) on the 8-15 port lead were showing ¿avoid.¿ they reprogrammed around the 2 affected contacts, which resolved the issue.No further complications were reported or anticipated.Additional information was revived from the rep and it was reported that the during a reprogramming, a connectivity check revealed an additional contact now has high impedance on the 0-7 lead (contact 5).The patient was programmed around these contacts.No further complications were reported or anticipated.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10203556
• MDR Text Key: 196864013
• Report Number: 3004209178-2020-11174
• 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: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2020
• Date Device Manufactured: 03/22/2019
• 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: 53 YR