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

Model Number 97714

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Undesired Nerve Stimulation (1980); Injury (2348)

Event Date 04/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Information was received from a manufacturer representative regarding a patient with an implantable neurostimulator (ins).It was reported that there was stimulation of the patient's "anal esfincter" by spinal cord stimulation.It was indicated that programming may have led or contributed to the issue.The patient was alive with an "anal esfincter" injury.Reprogramming was performed and the issue was resolved at the time of the report.

Manufacturer Narrative

The manufacturing site id was previously reported as 3007566237.Additional review indicates the correct manufacturing site id is 3004209178.

Event Description

Additional information was received from the company representative (rep) reporting the cause of the issue was ¿not tough¿, but seemed that the collocation of the electrodes could affect.In regards to the anal esfincter injury, the electrodes could contribute to the cause because one of them was in a low position.No further complications were reported or anticipated.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6540179
• MDR Text Key: 74310641
• Report Number: 3007566237-2017-01697
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2017
• Date Device Manufactured: 09/28/2016
• 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