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

Model Number 97714

Device Problems Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

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

Event Date 06/12/2017

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 97754, serial#: (b)(4), product type: recharger.Product id: pnma01411a004, 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 manufacturer representative regarding a patient.It was reported that the patient was having difficulty recharging their implantable neurostimulator (ins).The patient would have to hold the device in place with their hand as the belt was not comfortable to use.The manufacturer representative stated that the patient would have to press the device in order to get four black boxes.It was also reported that the device had overheated twice.The patient¿s healthcare provider (hcp) believed that the ins may be defective.The patient was provided with double-sided tape to hold recharging head in place.Proper use of the recharging belt was reviewed with the patient, including the extra bracket to provide ventilation and reduce overheating.It was suggested that the patient use yoga pants or leggings if they didn't want to use the belt.The patient was also switched to low-dose to reduce battery usage.The issue has not been resolved yet.No further complications were reported or anticipated.The patient¿s status at the time of this report is ¿alive, no injury.¿ indication for use is spinal pain.

Manufacturer Narrative

Product event summary evaluation determined that investigation is needed because it was reported that the patient was having difficulty charging their implantable neurostimulator (ins) as they had to press the device in order to get four coupling bars.It was also reported that the ins may be defective.The reported information is an allegation that suggests a possible failure of a device, labeling, or packaging to meet specifications.An assessment of the source information indicates there was no adverse event associated with the alleged device failure.Assessment determined that there is not an existing formal investigation for the issue identified in this event.However, a new formal investigation is not possible, because there is inadequate information to initiate formal investigation activities and the most likely cause cannot be determined; the root cause of the charging/coupling issue and defective ins remains unknown.Follow up has been conducted to obtain additional details regarding this event.Evaluation determined that investigation is needed because it was reported that the patient's implantable neurostimulator recharger (insr) overheated twice.The reported information is an allegation that suggests a possible failure of a device, labeling, or packaging to meet specifications.An assessment of the source information indicates there was no adverse event associated with the alleged device failure.Assessment determined that there is not an existing formal investigation for the issue identified in this event.However, a new formal investigation is not possible, because there is inadequate information to initiate formal investigation activities and the most likely cause cannot be determined; the root cause of the insr overheating remains unknown.Follow up has been conducted to obtain additional details regarding this event.Product id 97754 serial# (b)(4) product type recharger product id pnma01411a004 serial# unknown.Product type recharger if information is provided in the future, a supplemental report will be issued.

Event Description

(b)(6)2017 (b)(4) (rep): information was received from a manufacturer representative regarding a patient.It was reported that the patient was having difficulty recharging their implantable neurostimulator (ins).The patient would have to hold the device in place with their hand as the belt was not comfortable to use.The manufacturer representative stated that the patient would have to press the device in order to get four black boxes.It was also reported that the device had overheated twice.The patient¿s healthcare provider (hcp) believed that the ins may be defective.The patient was provided with double-sided tape to hold recharging head in place.Proper use of the recharging belt was reviewed with the patient, including the extra bracket to provide ventilation and reduce overheating.It was suggested that the patient use yoga pants or leggings if they didn¿t want to use the belt.The patient was also switched to low-dose to reduce battery usage.The issue has not been resolved yet.No further complications were reported or anticipated.The patient¿s status at the time of this report is ¿alive, no injury.¿ indication for use is spinal pain.(b)(6)2017.(rep): additional information: no new information was reported (b)(6)2017 email(rep) additional information was received from a representative.It was reported that brackets were provided to provide ventilation during recharging.No further complications were reported as a result of this event.

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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6645155
• MDR Text Key: 77772391
• Report Number: 3004209178-2017-12999
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2017
• Date Device Manufactured: 11/23/2016
• 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