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

Model Number 97702

Device Problems Migration or Expulsion of Device (1395); Unintended Collision (1429)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 3777-45, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.Product id: 3777-45, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the 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

Information was received from the patient via manufacturer representative.It was reported that the patient¿s leads were not covering their pain targets and that their physician believed that their leads had disconnected from their implantable neurostimulator (ins).The patient also reported a recent fall.Four days prior to the date of this report, the patient was seen in office by a manufacturer representative.At that time, impedances were normal and their stimulation was working.It was noted that the patient didn¿t report any issues at that time.An appointment was scheduled for (b)(6) 2017 for diagnostics.No further complications were reported.Indications for use are spinal pain and failed back surgery syndrome.

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 received from the manufacturer¿s representative (rep) reported it was determined via an x-ray and an impedance check that the leads weren¿t disconnected.Instead the cause of the pain targets not being covered and possible disconnection was due to lead migration.According to the rep.The issue of the leads not being connected has been resolved as the consumer was being referred for a lead revision.No further complications were reported.

Manufacturer Narrative

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 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6415338
• MDR Text Key: 70316294
• Report Number: 3004209178-2017-05884
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169109513
• UDI-Public: 00643169109513
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2017

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: 05/14/2016
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/14/2017
• Initial Date FDA Received: 03/17/2017
• Supplement Dates Manufacturer Received: Not provided; 03/23/2017
• Supplement Dates FDA Received: 03/29/2017; 10/17/2017
• Date Device Manufactured: 11/26/2014
• 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): Required Intervention
• Patient Age: 70 YR