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

Model Number 97702

Device Problems Premature Discharge of Battery (1057); Environmental Compatibility Problem (2929)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

Foreign: (b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient was concerned that her body was draining the ins too quickly and now she had to charge more frequently.The patient was charging every few weeks and now charged once a week.She was not sure if settings had changed or increased.It was noted that the patient was at the clinic and was referred to the manufacturer to explain how her body drains battery.The patient was to follow-up with the clinic on settings, and the issue was not resolved as of (b)(6) 2020.No surgical intervention occurred or was planned.The patient was also concerned that her body was the cause of her previous drained battery as that one only lasted two years.The previous implant drained quicker than normal.The patient was not aware of any environmental/external/patient factors that may have led or contributed to the issue.That ins was replaced with a rechargeable ins.No symptoms were reported, and the patient was alive with no injury.The issue occurred during normal use.Refer to mfr report # 3004209178-2020-20805 for the report of this event for the patient's currently implanted ins.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10922864
• MDR Text Key: 219180496
• Report Number: 3004209178-2020-20812
• 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: foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2016
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2020
• Date Device Manufactured: 08/15/2014
• 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 Outcome(s): Required Intervention