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

Model Number 97714

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

Patient Problems Stroke/CVA (1770); Dysphasia (2195)

Event Date 12/01/2014

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3998, lot #: (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 3998, lot #: (b)(4), implanted: (b)(6) 2014, product type: lead.Other relevant device(s) are: product id: 3998, serial/lot #: (b)(4), ubd: 19-aug-2017, udi#: (b)(4).Product id: 3998, serial/lot #: (b)(4), ubd: 19-aug-2017, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received regarding a patient with an implantable neurostimulator (ins), and it was reported that the patient has a speech impairment and claimed she woke up with it after her implant surgery.Additional information received from the patient's health care provider stated that the speech impairment was due to hypoglossal nerve palsy from a probable brainstem infarct.The hcp believed this probably occurred intra-op during the c 1-2 retrograde placement of the paddle electrode.It was reported a neurologist felt it was a stroke of the brain stem.It was reported the patient received therapy to resolve the speech impairment, but there was minimal change.Patient was implanted for non-malignant pain.

• Brand Name: SURESCAN
• 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: 8185061
• MDR Text Key: 131045250
• Report Number: 3004209178-2018-28074
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/20/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2014
• 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): Disability
• Patient Age: 51 YR
• Patient Weight: 56