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

Model Number 97714

Device Problems Migration or Expulsion of Device (1395); Energy Output Problem (1431); Battery Problem (2885); Charging Problem (2892); Environmental Compatibility Problem (2929); Positioning Problem (3009)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Scar Tissue (2060); Burning Sensation (2146); Therapeutic Response, Decreased (2271); Discomfort (2330); Complaint, Ill-Defined (2331); Loss of consciousness (2418); Weight Changes (2607)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), (b)(6), (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacture representative regarding a patient implanted with an implantable neurostimulator (ins).It was reported that the patient experienced poor pain relief starting in (b)(6) 2018.X-rays confirmed that a lead had migrated and so stimulation was reprogrammed back over the 9-10 disc space.It was also noted that during this same time the patient experienced overstimulation when sittings or moving, and this was also resolved through reprogramming.The patient was feeling tenderness at the ins site which gets worse with recharging and their hcp noted that this was part of the normal healing process and that the patient's weight loss has made the ins more superficial.The patient stated that they have 'lumps' at the ins and lead site and it was also confirmed by the hcp that this was scar tissue and was part of the normal healing.The patient was experiencing intermittent 'burning' between their shoulder blades and there was no explanation for this and no planes to address this issue.The patient passed out 3 weeks prior to the report due to back pain but the issue was resolved.The patient also mentioned faster depletion of the ins and a longer recharge interval in higher altitudes when visiting family in denver colorado.All of these issues were addressed and all issues were considered resolved at the time of the report.No further complications were 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: 7819784
• MDR Text Key: 118331895
• Report Number: 3004209178-2018-19249
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2018
• Date Device Manufactured: 08/19/2017
• 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: 62 YR