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

Model Number 97715

Device Problem Impedance Problem (2950)

Patient Problems Unspecified Infection (1930); Pain (1994); Discharge (2225); Complaint, Ill-Defined (2331); Skin Inflammation (2443); Fluid Discharge (2686)

Event Date 02/07/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3777-60, serial#: (b)(4), implanted: (b)(6) 2011, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient via manufacturer representative, regarding patient's implantable neurostimulator (ins).Patient had a small blistered area seeping blood tinged discharge on the top of neck/base of head in the back near the occipital lead area.Patient stated she heard a pop and the area started to hurt.There were no known causes.Checked impedances and noted 0,1,4,7 are all over impedance.Patient was prescribed antibiotics.Reprogrammed lead and patient was satisfied with stim coverage.The issue was resolved.Hcp had no further information.Patient's weight was asked but unknown.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: 9751435
• MDR Text Key: 184334327
• Report Number: 3004209178-2020-04038
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2020
• Date Device Manufactured: 04/22/2018
• 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 Outcome(s): Other
• Patient Age: 71 YR