MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97714

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Scar Tissue (2060); Weight Changes (2607)

Event Date 11/01/2016

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 977a160, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 977a160, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.

Event Description

Information was received about a patient implanted with an implantable neurostimulator (ins).The patient reports that one if their wires in the scar tissue in their back was coming out.The patient neurologist took x-rays and stated that the wires were out of place.It was noted that the patient had lost (b)(6) pounds.The patient wanted to schedule an appointment with a manufacturing representative (rep) and their health care provider.Indication for use includes spinal pain.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.The patient reports that she was asleep when the rep called her for reprogramming and is requesting that the rep call her back.The rep was notified and indicated that they would followup with the patient.

Manufacturer Narrative

Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6305917
• MDR Text Key: 66662513
• Report Number: 3004209178-2017-02675
• Device Sequence Number: 1
• Product Code: GZB
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2017

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: 10/28/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2017
• Initial Date FDA Received: 02/06/2017
• Supplement Dates Manufacturer Received: Not provided; 02/06/2017
• Supplement Dates FDA Received: 02/08/2017; 09/29/2017
• Date Device Manufactured: 12/04/2013
• 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: 51 YR