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

Model Number 97714

Device Problems Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885); Charging Problem (2892)

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

Event Date 11/06/2016

Event Type  malfunction  

Event Description

Information was received about a patient implanted with an implantable neurostimulator (ins).A manufacturing representative (rep) reports that they were currently recovering the patient's battery from an overdischarge (od).It was noted that this is the patient's second od.The rep stated that the patient was charging normally and was getting either 4-6 bars, depending on the placement of the antenna.The rep stated that they would continue charging with the patient and clear the por.The patient stated that the event occurred a couple of months ago.Indication for use includes non-malignant pain and chronic low back pain.The rep called back three days later stating that they had been charging the ins and it reached 25% and was flashing on the 50% quartile but when they read it with the 8840 it said the ins was discharged and wouldn't allow them to enter a session.It was reviewed that the charge level may take a few minutes to register/up date on 8840 or patient programmer (pp).Caller states they went back to insr and it just now showed 25% and then went to empty.It was reviewed that the ins may be acting erratically following the overdischarge and the patient should continue to charge to see if it normalizes and if they do not clear por before leaving the office, the patient should not press any on/off buttons for ins until por is cleared.The patient called the same day stating that they had charged the ins all weekend and its still not taking a charge.The caller reports seeing por info on the insr.The called dropped and patient services left the patient a voice mail.It was noted that the patient had called earlier that day stating that their ins was od.The patient called back and stated that she had been charging since last thursday.She states that the ins charge level does not go past 25%, but will every so often go to por screen.The patient states that she has been able to clear the por every time but the ins would charge up and almost immediately revert back to 25%.It was reviewed that the charging issues may be due to the overdischarge.The patient was instructed not to turn their therapy on/off during this time.Patient services recommended the patient to consult with their managing rep.It was noted that the patient has an appointment with her doctor on (b)(6).On (b)(6) 2016 the rep indicated that the patient still cannot get the battery to fully charge.The rep was trying to contact the patient to work with tech support.

Event Description

Additional information was received from a manufacturer's representative (rep).It was reported that the overdischarge had not been resolved.

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: 6261504
• MDR Text Key: 65207389
• Report Number: 3004209178-2017-01169
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2017
• Date Device Manufactured: 04/10/2014
• 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 Age: 55 YR