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

Model Number 97714

Device Problems Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Battery Problem (2885); Communication or Transmission Problem (2896)

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

Event Date 05/29/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received regarding a patient implanted with a neurostimulator (ins) used for spinal pain.Manufacturer representative reported the patient¿s battery was overdischarged due to not charging.It was reported that they attempted to communicate with the battery but were unable to.The patient did not have their recharger and made an appointment (b)(6) 2018 to trickle charge.Additional information was received from a manufacture representative (rep) on (b)(6) 2018.The battery was overdischarged.The rep performed a trickle charge three times but they were unsuccessful.The patient felt better so they stopped recharging which led to the overdischarge.The patient would make an appointment to be seen regarding an implantable neurostimulator (ins) change.It was unknown if surgical intervention was planned.The issue was not resolved but the patient was noted to be alive with no injury.Additional information was received from the health care provider (hcp) via a manufacturer representative on 2018-06-11 confirming that a surgical intervention was planned but had not been scheduled.No further complications were reported.

Manufacturer Narrative

A supplemental report will be sent when analysis results are available.H6: contains all applicable codes at this time.If information is provided in the future, a supplemental report will be issued.

Event Description

It was confirmed that the device was replaced on (b)(6) 2018.The patient recovered without sequela.No further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

Analysis determined that the battery had a reduced capacity.If information is provided in the future, a supplemental report will be issued.

• 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: 7597371
• MDR Text Key: 110941434
• Report Number: 3004209178-2018-13329
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2018

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: 02/14/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 06/13/2018
• Supplement Dates Manufacturer Received: 07/11/2018; 09/10/2018; 08/08/2018
• Supplement Dates FDA Received: 07/13/2018; 09/18/2018; 10/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2017
• 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: 71 YR