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

Model Number 97715

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Incontinence (1928); Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 02/15/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received via a manufacturer representative from a consumer regarding a patient who was implanted with a neurostimulator on (b)(6) 2018.It was reported that the patient had a stroke three days after implant and was reporting incontinence.On the day of the report, the manufacturer representative did a reprogramming to help her pain and discussed with the patient how to turn off the stimulator to see if that would help relieve any other symptoms.The issue was not resolved at the time of the report.Additional information was received from a manufacturer representative and was confirmed with a health care provider regarding the patient on (b)(6) 2018.It was reported that the manufacturer representative was unsure of the date that the incontinence began.The patient did not specify a date, only that it had begun sometime after her implant.The manufacturer representative does not know if the incontinence is pre-existing.The manufacturer representative only knows that the patient reported the incontinence after the implant.There was no surgical intervention planned or performed at the time of the report.The patient¿s medical history was noted as stroke and incontinence.

• 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: 7893807
• MDR Text Key: 120862119
• Report Number: 3004209178-2018-21096
• 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: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2018
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2018
• Date Device Manufactured: 01/13/2018
• 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: 82 YR
• Patient Weight: 73