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

Model Number 97715

Device Problems Failure to Deliver Energy (1211); Failure to Interrogate (1332); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problems Seroma (2069); Complaint, Ill-Defined (2331)

Event Date 03/09/2020

Event Type  Injury  

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information received from the manufacturing representative reported that the patient still had recharging problems.The recharger could not find the implantable neurostimulator (ins).It showed the message rm04 and two days later there was no more communication possible.

Manufacturer Narrative

Concomitant medical products: product id 97745, serial# (b)(4), product type programmer; patient product id 97755, serial# (b)(4), product type recharger.(b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the healthcare professional via the manufacturer representative regarding a patient with an implantable neurostimulator (ins).It was reported that the ins was at risk of coming out thru the skin, therefore the ins was repositioned on (b)(6) 2020.Recharging was not possible after the ins was repositioned.Normal usage, disconnection, and reconnection with the ins was possible.Connection with the controller was possible, but not possible with the clinician programmer.Repositioning of antenna showed no difference of recharging success and stimulation was off due to an empty battery, ins discharge occurred on (b)(6) 2020.Disconnecting and reconnecting with a new recharger was not successful.The manufacture representative tried disenabling and re-enabling the ins, different attempts and different position with always the same result ¿ too weak charging quality with message ¿please reposition the antenna¿.The ins did not feel too deep but could be a ¿few degrees¿.The physician checked with ultrasonic if there was some liquid.After aspiration of this liquid the charging was once again possible.It took longer but it worked.No further intervention was planned.No further complications were reported or anticipated.

• Brand Name: INTELLIS
• 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: 9917843
• MDR Text Key: 187331292
• Report Number: 3004209178-2020-06612
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2020
• Date Device Manufactured: 04/01/2019
• 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