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

Model Number 97715

Device Problem Energy Output To Patient Tissue Incorrect (1209)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 12/04/2017

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 manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins) for spinal pain and lumbar radiculopathy.The patient feels sensation in their hips and legs even with their ins off.They used the ekg to confirm the ins is off.The rep would discuss the issues with the patient¿s healthcare professional (hcp).No further complications were reported/are anticipated.

Manufacturer Narrative

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

Event Description

Information was received from a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins) for spinal pain and lumbar radiculopathy.The patient feels sensation in their hips and legs even with their ins off.They used the ekg to confirm the ins is off.The rep would discuss the issues with the patient¿s healthcare professional (hcp).No further complications were reported/are anticipated.On 2017-12-18 rep): additional information received from a manufacturer representative (rep) reported that the cause of the issues were never determined.The rep also reported that the patient¿s medical doctor was going to send them to a neurologist for evaluation.There were no further complications 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7126299
• MDR Text Key: 95743364
• Report Number: 3004209178-2017-26187
• 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,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2018
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 12/18/2017
• Supplement Dates Manufacturer Received: 12/18/2017
• Supplement Dates FDA Received: 01/14/2018
• Date Device Manufactured: 11/16/2017
• 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: 63 YR