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

Model Number 97714

Device Problems Overheating of Device (1437); Pocket Stimulation (1463); Device Operates Differently Than Expected (2913)

Patient Problems Edema (1820); Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Discomfort (2330)

Event Date 12/16/2016

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A consumer reported via the manufacturer¿s representative (rep) they were implanted on (b)(6) and the procedure ¿went smoothly¿ but either on (b)(6) when they increased stimulation they had increased pain at the pocket site (the site was already painful due to the incision).The rep.Asked the consumer if they were feeling pocket stimulation but the consumer described it as increased pain which the rep.Thought maybe was pocket stimulation discomfort that was aggravating the edema.The rep.Was scheduled to see the consumer in a week for follow-up.Relevant medical history includes non-malignant pain.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturer representative reported that the patient's battery was leaking voltage on the left lead.The left lead was reprogrammed and the patient no longer feels the burning sensation.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturer representative reported that the patient was experiencing a burning sensation at the site of the implantable neurostimulator (ins) and around their ribs.It was reported that the patient wasn¿t receiving therapeutic benefit and that the change in therapy wasn¿t related to positional movement.The patient had been decreasing stimulation due to the burning sensation in the ins pocket.The manufacturer representative was to attempt to reprogram around the issue and if that failed, they were to speak with a healthcare provider (hcp) about a revision.It was noted that the burning sensation had been occurring off and on since implant.The issue was considered to be a gradual change in therapy/symptoms as the patient reported that it had been increasing.

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 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6219818
• MDR Text Key: 63803005
• Report Number: 3004209178-2017-00095
• Device Sequence Number: 1
• Product Code: GZB
• 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,Followup,Followup
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2017
• Date Device Manufactured: 09/02/2016
• 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 Age: 65 YR