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

Model Number 97714

Device Problems Device Difficult to Program or Calibrate (1496); Unstable (1667); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Malposition of Device (2616); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Increased Sensitivity (2065); Discomfort (2330)

Event Date 06/22/2015

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer¿s representative regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient's stimulator was overdischarged due to patient noncompliance but the patient also struggled with charging due to poor connection.The representative set up an appointment to perform a prm.This issue had not been resolved.Additional information received from the representative and consumer.It was reported that the representative didn't determine the cause with regards to the patient struggling to charge and poor connection.The representative thought that the battery had either flipped or was implanted too deep to allow for adequate coupling of the recharger to their battery- they were unable to receive any coupling bars during their visit.They struggled to set their adaptive stimulation for lying on back position as it took them about 15 minutes to connect to their battery in that position.At home the patient needed to sit at the edge of their recliner chair, bend over and then with the paddle over their battery they pulled down on the straps of their recharging belt to charge.They had to remain in that position for the duration of their recharge session.The maximum number of bars they had been able to obtain since implant was only 4 bars.They were scheduled for an appointment to meet with their surgeon on (b)(6) 2018 to discuss their options.The overdischarge had been resolved.The patient reported that initially they received 6 shaded bars but were only receiving 2-4 shaded when recharging.When they met with the representative they advised they called patient services and order adhesive discs.The patient reported that they discussed how the implant could be too deep and that the right corner seemed deeper than the upper half.The patient noted they were more sensitive at the ins site and ribs on their right side; the ins was irritating their ribs.No further complications reported.

• 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: 7557707
• MDR Text Key: 109761898
• Report Number: 3004209178-2018-12271
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2018
• Date Device Manufactured: 04/13/2015
• 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: 48 YR