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

Model Number 97714

Device Problems Unintended Collision (1429); Therapy Delivered to Incorrect Body Area (1508); Unable to Obtain Readings (1516)

Patient Problems Incontinence (1928); Undesired Nerve Stimulation (1980); Discomfort (2330)

Event Date 05/01/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer, via a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins) for spinal pain.It was reported that, after a fall, the patient was urinating when the stimulation was turned on and also had stimulation in their stomach which was uncomfortable.The patient had the stimulation off since the fall.This was noted to be a sudden change in therapy.The rep saw xxx's during the impedance test but then increased the default parameters to 1.5v and resolved issue.Normal impedances were observed and the rep was going to attempt reprogramming and possibly get x-rays to see if the leads had migrated.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from the representative.It was reported that the cause of the stomach stimulation and patient urinating when the stimulation was turned on was not determined.The patient's device was reprogrammed and during the reprogramming the issue was resolved.The patient's weight was unknown.This information was confirmed with the physician/account.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: 7317206
• MDR Text Key: 101628182
• Report Number: 3004209178-2018-04513
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2018
• Date Device Manufactured: 02/20/2015
• 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: 63 YR