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 Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Insufficient Information (3190)

Patient Problems Undesired Nerve Stimulation (1980); Scar Tissue (2060); Therapeutic Effects, Unexpected (2099); Malaise (2359)

Event Date 02/18/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the only stimulation from the ins was in their stomach and not in their lower back.The stimulation in their stomach made them sick because it wasn't touching where is was supposed to.The patient added that they told their healthcare provider that the ins wasn't working properly before they were released from the hospital on the day of the ins implant surgery.They spent a couple of months reprogramming the ins, but still couldn't get the stimulation to reach their lower back.They tried different programs and the healthcare provider had to eventually scrape the scar tissue off of their spine.They noted the scar went up to their thoracic, under the c-spine.The healthcare provider had to move the ins and wires.They reprogrammed the ins and found a couple of programs that worked really well.The ins was implanted in (b)(6) 2015 and the correction surgery was done in (b)(6) 2015.This conflicts with current records that indicated the patient was implanted in 2016.No further complications were reported or anticipated.

• 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: 8985914
• MDR Text Key: 160995544
• Report Number: 3004209178-2019-17385
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2019
• Date Device Manufactured: 01/22/2016
• 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: 43 YR