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

Model Number 97714

Device Problems Break (1069); Disconnection (1171); Failure to Deliver Energy (1211); High impedance (1291); Unable to Obtain Readings (1516)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 03/17/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 977a275, product type: lead.Product id 977a275, product type: lead.(b)(4).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 chronic intractable pain patient reported through a manufacturer representative (rep) that they had experienced a ¿cessation of stimulation.¿ it was stated the patient normally felt stimulation with their output set to 3 v, however the patient had increased their stimulation up to 4.8 v at the time of report and yet ¿no stimulation was felt.¿ the patient tried increasing their stimulation again at the time of report while in contact with a manufacturer representative, but the result was the same.The following the day the patient met with a manufacturer presentative to troubleshoot the event.Impedance testing was initially performed at 0.7 v, however values could not be attained, as ¿xxx was displayed.¿ impedance testing was then retried at both 1.5 v and 3 v and ¿high resistance values¿ were displayed each time.The impedances were ¿>40000¿ ohms for all values.The rep reported to the patient¿s physician at that time that ¿the stimulation had stopped due to high resistance values.¿ it was noted that a ¿lead disconnection was suspected¿ or ¿fracture of the leads was suspected.¿ please note the ¿disconnection¿ and ¿fracture¿ indications were alternate translations of the same report; it was unknown at the time of this report which translation was correct.The event was unresolved at the time of report.The patient¿s cessation of stimulation was described as a health hazard at that time.No surgical interventions were performed and it was ¿unknown¿ whether any were planned.

Event Description

Additional information clarified that a "fracture of the leads was suspected," not a lead disconnection.It was noted the physician had consulted with the patient regarding explanting their system or replacing the leads, however the patient then stopped visiting the hospital.As a result, it was unknown whether the issue had been resolved as of 2016-apr-24.

Manufacturer Narrative

Corrected information: if information is provided in the future, a supplemental report will be issued.

• Brand Name: RESTORE SENSOR MRI
• 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: 5564312
• MDR Text Key: 42269096
• Report Number: 3004209178-2016-07117
• Device Sequence Number: 1
• Product Code: LGW
• 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: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• 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?: No
• Date Manufacturer Received: 04/22/2016
• 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