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

Model Number 97714

Device Problems Energy Output To Patient Tissue Incorrect (1209); Device Displays Incorrect Message (2591); Battery Problem (2885)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37791, serial# unknown, product type: recharger.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient with an implantable neurostimulator (ins) for the treatment of non-malignant pain.It was re ported that the patient¿s ins was charged a week ago a little over ¾ full.The patient stated the ins recharger (insr) took a while to get coupling when they charged.The patient stated the ins died during the night.Two days prior, they were shutting the stimulation off and on because it was ¿driving her nuts to leave it on¿.They left it on all night and the next morning it was dead.The patient stated they still felt residual tingling.They stated the charge on the ins usually lasted for a month or more.They used it more but they stated it should not have gone dead after 3 days.The patient checked the ins with the patient programmer (pp) and got the warning screen to recharge and that the ins was dead.The patient was on vacation and did not bring the insr.A replacement insr antenna was sent to address the coupling issue.The patient felt severe pain.They also stated the ins was protruding because they had lost weight due to an unrelated sickness.The patient also inquired about the battery life and this information was reviewed.No further patient complications were reported as a result of this event.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7464493
• MDR Text Key: 107101867
• Report Number: 3004209178-2018-09328
• Device Sequence Number: 1
• Product Code: LGW
• 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
• Report Date: 04/26/2018

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: 09/14/2016
• 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: 03/30/2018
• Initial Date FDA Received: 04/26/2018
• Date Device Manufactured: 10/27/2015
• 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
• Patient Age: 55 YR