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); Disconnection (1171); High impedance (1291); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97714, serial#: (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2020, product type: implantable neurostimulator.Product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2016, product type: lead.Product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2016, product type: lead.Product id: 977a275, serial/lot #: (b)(4), ubd: 27-jun-2020, udi#: (b)(4).Product id: 977a275, serial/lot #: (b)(4), ubd: 23-feb-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

When the implantable neurostimulator was replaced, the physician stated that the 0-7 lead was not seated properly in the old implantable neurostimulator.When he put the same lead into the new battery, after he screwed down, the lead pulled out.They were able to get it secured after inserting again and screwing down with the impedance high on (b)(6) 2015.The patient was reprogrammed post-op with the out of range issues.Impedances were rechecked and 2/4/8/15 were all greater than 40,000 ohms.The manufacturer representative was able to reprogram to get adequate coverage and the patient has their follow-up post-op appointment on (b)(6) 2020.

• 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: 11008087
• MDR Text Key: 221541970
• Report Number: 3004209178-2020-21861
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2020
• Date Device Manufactured: 11/06/2020
• 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: 80 YR