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

Model Number 97714

Device Problems Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Unstable (1667); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A consumer reported the patient lost weight within the last six months and the implantable neurostimulator (ins) had moved and flipped on its side.Currently they were seeing the reposition antenna screen on the recharger, the poor communication screen on the programmer, were unable to communicate using the programmer or recharger, and were unable to recharge.Relevant medical history includes spinal pain.

Manufacturer Narrative

(b)(4) were removed as device allegation was refuted.

Event Description

Patient reported they had hard time charging battery.The medical representative met with the patient and the patient reported that she couldn't charge her implantable neurostimulator battery.It was found that it was overdischarged.The medical representative reported that patient compliance may have led to the issue.Because of time constraints, they set up a time to meet and perform a trickle charge on (b)(6) 2016.On the same day, generator was assessed and not found to be moved or flipped.On (b)(6) 2016 the caller reported, overdischarged battery had been resolved.The medical representative performed a physician recharge and cleared the power on reset (por).They provided in depth overview of how to charge and the importance of charging the battery.No patient symptoms were reported.

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 healthcare provider (hcp) reported the implantable neurostimulator (ins) wasn¿t flipped.It was further reported the consumer did have problems charging and interrogating the device but it was later determined the cause of the issues was the consumer not charging the device resulting in the manufacturer¿s representative (rep) needing to perform a ¿generator recharge.¿ following this the device was functioning correctly.

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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5956430
• MDR Text Key: 54996792
• Report Number: 3004209178-2016-19068
• Device Sequence Number: 1
• Product Code: GZB
• 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,Followup
• Report Date: 11/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/03/2015
• 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