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

Model Number 97712

Device Problems Migration or Expulsion of Device (1395); Unstable (1667); Device Displays Incorrect Message (2591); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/12/2017

Event Type  malfunction  

Manufacturer Narrative

Section d references the main component of the system and other applicable components are: product id: 37791, serial# unknown, product type: recharger.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

Information was received from a patient with an implantable neurostimulator (ins) for the treatment of non-malignant pain.It was reported that there was poor coupling with recharging.After attempting antenna locate, the patient reported getting a 68 but still had 0 coupling boxes.A replacement antenna was sent.No further complications were reported/expected.Additional information from the consumer on 2017-07-24 was reported that the patient needed a new antenna because recharger was not connecting.The recharging antenna was damaged.The patient reported they were getting all boxes filled and now can only get 2 boxes or none.Additional information was received from the consumer on 2017-07-31 reporting that the patient saw the hcp about the charging issues.The hcp wanted to conduct imaging and wanted to verify mri compatibility.The patient was only seeing the ins battery depleted warning screen on the patient programmer.The patient explained that they could not charge the ins.The new insr antenna did not resolve the charging issues.Additional information from the consumer via a manufacturer representative on 2017-07-31 reported that there was a battery issue reported.It was reported that the battery had not been charged for about 3 weeks prior to the report.The patient had issues with their recharger in the past.The battery had always been difficult to charge.The battery was checked with the clinician programmer and it said ¿neurostimulator battery is dead.Replace neurostimulator battery.¿ the error code 5 was showing.The manufacturer representative checked the battery with the recharger too and it displayed a normal recharger screen but the battery was at 0% charge with only 2 coupling boxes shaded in.Using the antenna locate (al) feature, the resulting range was 74-88.The patient had lost weight since surgery and stated that they battery felt like it had slid down in the pocket.X-rays were taken on the day of the report.The battery felt slopped down in the pocket.The manufacturer representative could feel the header of the battery and then it slopped down deeper into the tissue.The health care professional (hcp) would like the whole recharger replaced.It was unknown if there was a surgical intervention planned.Patient weight and medical history were asked but unknown.The patient status was confirmed to be alive with no injury.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information received from the patient reiterated the previously reported recharging issues and stated that their hcp told them that the ins pocket did not heal properly from the implant surgery.The patient reported that the ins had moved and tilted.The patient was unable to find or maintain coupling boxes so a new ins recharger was requested to see if coupling could improve, and if this did not resolve the issue another surgery would be attempted.A new ins recharger was sent to the patient.

• 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6759990
• MDR Text Key: 81614085
• Report Number: 3004209178-2017-16048
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169109506
• UDI-Public: 00643169109506
• 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: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2017
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2017
• 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
• Patient Age: 29 YR