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

Model Number 97714

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

Patient Problems Pain (1994); Discomfort (2330); Weight Changes (2607)

Event Date 02/26/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2015, product type: lead.Product id : 977a260, serial#: (b)(4), implanted: (b)(6) 2015, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

A health care provider (hcp) reported the patient was extremely thin and boney and the implantable neurostimulator (ins) and coiled leads under battery were bothering them anytime they lay on their back.The patient had pain at the ins site/ pocket.The patient discussed with the hcp moving the ins to another location as the patient wanted the ins removed completely.The patient¿s husband disagreed with the removal as the ins did relieve the patient¿s chronic pain.The patient¿s indication for use includes non-malignant pain and failed back surgery syndrome.The change in therapy/ symptoms was considered sudden.The patient reported that the entire spinal cord stimulation system was removed on (b)(6) 2015.The patient reported that following permanent implant of the spinal cord stimulation system, her weight went from (b)(6) to (b)(6) pounds.The implantable neurostimulator area was painful to the touch, and she could not apply any amount of pressure in the area.The patient could not take it, so she just had it all removed to resolve the issue.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: 12385706
• MDR Text Key: 268729640
• Report Number: 3004209178-2021-13088
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2021
• Date Device Manufactured: 01/19/2015
• 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): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 45