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

Model Number 97714

Device Problems Device Displays Incorrect Message (2591); Battery Problem (2885); Charging Problem (2892)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 12/20/2015

Event Type  Injury  

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

The healthcare professional (hcp) of a clinical study reported that the implantable neurostimulator (ins) was unable to recharge.The clinical diagnosis was restless leg.The outcome was ongoing.No actions were taken as interventions.The patient reported restless sensation so they were not using the stimulator.The stimulator programmer gave a message and the patient was not able to charge.The etiology was reported as possibly related to the device or therapy and not related to the implant procedure.The etiology was noted as related to the recharge process.The reason for non-compliance is related to the subject.The patient had stimulation running at high frequency and did not maintain recharging so the system battery depleted.Additional information received reported the ins was replaced and the patient recovered without sequelae on (b)(6) 2016.

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: 6159211
• MDR Text Key: 62102916
• Report Number: 3004209178-2016-25556
• 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: health professional,study
• Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 12/09/2016

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: 04/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 12/09/2016
• Supplement Dates Manufacturer Received: 11/18/2016
• Supplement Dates FDA Received: 09/27/2017
• Date Device Manufactured: 06/04/2014
• 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: 43 YR